[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"MMI (Medical Microinstruments, Inc.)\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":191},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,43,73,98,113,135,146,170],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100053425","a-post-market-real-world-experience-expanding-access-to-care-by-incorporating-the-symani-surgical-system-and-enabling-surgeons-100053425",false,"NCT06725030","A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons","PRECISE: A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons","PRECISE","Pre Operative Inclusion Criteria:\n\n1. At least 22 years of age\n2. Patient agrees to participate in the study, return for all required follow-up visits, complete all study procedures, and has willingly provided written informed consent after receiving all information related to the study, its requirements, and the robotic assisted procedure\n3. Patient has a clinical indication for a microsurgical anastomosis of vessels between 0.1 and 2.5 mm in conjunction with open free-flap surgery of the breast or extremities and\u002For lymphovenous anastomosis surgery of the extremities\n4. Investigator deems the candidate acceptable for free flap transfer surgery and\u002For lymphovenous anastomosis surgery with a robotic assisted microsurgical anastomosis in accordance with the Symani System's Instructions for Use (IFU)\n\nCohort Specific Pre- Operative Inclusion Criteria:\n\nFree Tissue Transfer Surgery: N\u002FA\n\nLymphovenous Anastomosis Surgery\n\n1. Swelling of one limb that is not completely reversed by elevation or compression\n2. Stage I-II lymphedema at screening, based on the International Society of Lymphology (ISL) staging system\n3. At least one of the following positive quantitative measurements:\n\n   1. Volumetry differential between affected limb and contralateral limb must be at least 10% of the other\n   2. Bioimpedance (L-Dex) differential, if feasible, between affected limb and contralateral limb of at least 10 units\n4. Completion of a full course of complete decongestive therapy (CDT), according to ISL guidelines, for at least 12 weeks prior to screening, including use of compression garments for at least 12 weeks without change in regimen\n5. Willingness to comply with recommended regimen of self-care, with consistent use of appropriately sized compression garments from screening through the entire study duration (through the 3-month follow-up visit).\n\nPre-Operative Exclusion Criteria:\n\n1. Patients who are incapable and\u002For unwilling to provide informed consent\n2. Active systemic infection under treatment with intravenous antibiotics\n3. Clinically significant cardiovascular, digestive, respiratory, endocrine, or central nervous system disorders, previous mental disorders, or other disorders that may significantly affect the data collection or the ability to comply with the protocol per the investigators discretion\n4. Known history of significant bleeding, coagulopathy, or Von Willebrand's disease\n5. Patients with implanted pacemaker\n6. Planned vein graft\n7. Currently receiving chemotherapy or radiation therapy\n8. History of chronic kidney disease\n9. History of chronic liver disease\n10. Currently enrolled in any other investigational clinical studies that the investigator believes may impact patient safety or outcomes\n11. Patients belonging to vulnerable populations, such as pregnant women, or ineligible to participate for other reasons in the judgement of the investigator\n\nCohort Specific Pre-Operative Exclusion Criteria:\n\nFree Tissue Transplant Surgery:\n\n1. Patients with buried flaps\n2. Multiple flaps planned for the procedure\n\nLymphovenous Anastomosis Surgery:\n\n1. Patients \\> 75 years of age\n2. Patients with prior lymphatic reconstruction surgery\n3. Patients with venous edema (arising from increased capillary filtration)\n4. Patients with other medical conditions that could lead to acute limb edema, such as (but not limited to) acute venous thrombosis or heart failure\n5. Patients with other medical conditions that could result in symptoms which overlap symptoms of lymphedema\n6. Current infection in the affected limb\n7. Patients who experience more than one episode of cellulitis in a six month period over the past two years\n8. Current evidence or a history of malignancy within the past 6 months (if the participant has undergone cancer treatment, this must have been completed \\> 6 months prior to enrollment)\n9. Known iodine sensitivity\n10. Patient's lymphatic disease is due to lipedema\n11. Patients with bilateral lymphedema or lymphedema in multiple anatomical locations\n\nIntra Operative Exclusion Criteria:\n\n1. Any presenting condition discovered intraoperatively that, in the opinion of the investigator, would make participating in this study not in the patient's best interest\n2. The patient does not have at least one robotic stitch attempted during the index procedure","ALL","22 Years",{"count":20,"type":21},455,"ESTIMATED","OBSERVATIONAL","The objective of this study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during free tissue transfer surgery and lymphovenous anastomosis surgery.\n\nThe primary endpoints are:\n\n* Effectiveness- Rate of intraoperative anastomosis patency at first attempt.\n* Safety- Freedom from device-related adverse events.\n\nParticipants will receive treatment as standard of care and be asked to:\n\n* Allow the researchers to access and use their information.\n* If participants are undergoing a lymphedema procedure, they will be asked to undergo a questionnaire as part of the study.\n* Participants will be asked to comply with the follow-up visits and complete all study procedures\u002Fquestionnaires as outlined in the protocol.",[25,26,27,28,29],"Open Surgery","Lymphedema","Free Tissue Transfer","Microsurgery","Anastomosis, Surgical","RECRUITING","2026-07-10",{"date":33,"type":34},"2026-07-13","ACTUAL",{"date":36,"type":34},"2025-09-22",{"date":38,"type":21},"2027-12-01",{"name":40,"class":41},"MMI (Medical Microinstruments, Inc.)","INDUSTRY",6,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":61,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100054093","clinical-lymphedema-evaluation---advancing-reconstruction-of-head-and-neck-lymphatics-with-symani-100054093","NCT07311876","Clinical Lymphedema Evaluation - Advancing Reconstruction of Head and Neck Lymphatics With Symani","CLEAR","Inclusion Criteria:\n\n1. At least 22 years of age\n2. Patients with acquired head and neck lymphedema with external lymphedema or both external and internal lymphedema\n3. Patient agrees to participate in the study, return for all required follow-up visits, complete all study procedures, and has willingly provided written informed consent after receiving all information related to the study, its requirements, and the robotic-assisted procedure\n4. Patient has a clinical indication for a microsurgical anastomosis of vessels between 0.1 and 2.5 mm in conjunction with lymphatic reconstruction of the head and neck\n5. Patient has been compliant with complete decongestive therapy (CDT) for at least 4 weeks\n6. Patient has undergone lymphatic mapping of the head and neck and functional lymphatic structures for reconstruction have been identified\n7. Investigator deems the candidate acceptable for lymphatic reconstruction with a robotic-assisted microsurgical anastomosis in accordance with the Symani System's Instructions for Use (IFU)\n8. Willingness to comply with recommended regimen of self-care, with consistent use of manual lymph drainage and\u002For appropriately sized compression garments from screening through the entire study duration (through the 6-month follow-up visit).\n\nExclusion Criteria:\n\n1. Patient who is incapable and\u002For unwilling to provide informed consent\n2. Patients with irreversible head and neck lymphedema, defined as stage 3 of the MD Anderson Cancer Center Head and Neck Lymphedema Rating Scale\n3. Active systemic infection under treatment with intravenous antibiotics\n4. Clinically significant cardiovascular, digestive, respiratory, endocrine, or central nervous system disorders, previous mental disorders, or other disorders that may significantly affect the data collection or the ability to comply with the protocol per the investigator's discretion\n5. Known history of significant bleeding, coagulopathy, or Von Willebrand's disease\n6. Currently receiving chemotherapy or radiation therapy (uncontrolled tumor)\n7. A history of malignancy or cancer treatment within the past 6 months (tumor control)\n8. Patient with unsatisfactory manual lymphatic drainage and\u002For compression garments for at least six months\n9. Patient with prior lymphatic reconstruction in the targeted head \\& neck area\n10. Patient's lymphatic disease is due to lipedema\n11. Patients with other medical conditions that could result in symptoms which overlap symptoms of lymphedema (e.g., thrombosis in the external or internal jugular vein)\n12. Current infection in the head \\& neck area in which lymphedema is present\n13. Currently enrolled in any other investigational clinical studies that the investigator believes may impact patient safety or outcomes\n14. Patient is ineligible to participate for other reasons in the judgement of the investigator",{"count":51,"type":21},30,"INTERVENTIONAL",[54],"NA","The objective of this study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during open lymphatic reconstruction in the head and neck.",[26,57,58,59,60],"Lymphedema of Face","Internal Lymphedema","External Lymphedema","Lymphedema of Neck",[62,63,64],"lymphedema","head and neck lymphedema","symani","2026-07-09",{"date":33,"type":34},{"date":68,"type":34},"2026-06-19",{"date":70,"type":21},"2028-02-01",{"name":40,"class":41},1,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":81,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":52,"phases":84,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},"100606642","robotic-enabled-microsurgical-intervention-for-neurodegenerative-disease-100606642","NCT07178210","Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease","Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease - A Global, Prospective, Early Feasibility Study in Alzheimer's Patients","REMIND","Inclusion Criteria:\n\n1. Patient aged 50 or older\n2. Patient has confirmed mild to moderate Alzheimer's Disease according to the National Institute of Aging-Alzheimer's Association (NIA-AA) criteria\n3. Patient has a positive amyloid PET test and\u002For a positive CSF t-tau\u002Famyloid-beta-42 test\n4. Patient has an MMSE score within the mild to moderate range (21-26 and 10-20)\n5. Patient has CDR-SB score within the mild to moderate range; mild is 4.5to 9.0 and moderate is 9.5 to 15.5\n6. Patient has confirmed extracranial lymphatic abnormalities in the head and neck region as identified by preoperative imaging\n7. Investigator deems the candidate acceptable for lymphatic surgery with a robotic-assisted microsurgical anastomosis in accordance with the Symani System's Instructions for Use (IFU)\n8. Patient or their legally authorized representative agrees to participate in the study, return for all required follow-up visits, complete all study procedures, and has willingly provided written informed consent after receiving all information related to the study, its requirements, and the robotic assisted procedure\n\nExclusion Criteria:\n\n1. Patient (or their legally authorized representative) is unwilling to provide informed consent\n2. Patient has suspected dementia of other type, e.g., Lewy body, frontotemporal disorder, vascular, etc.\n3. Patient has documented or suspected neurological or intracranial conditions such as cerebrovascular accident, tumors, intracranial space occupying lesions, seizures or other intracranial\u002Fneurological conditions that may affect their safety in the study.\n4. History of head and neck radiation exposure\n5. Patient with severe kidney disease (GFR \\\u003C30 mL\u002Fmin\u002F1.73m2)\n6. Patient with acute kidney injury\n7. Active systemic infection under treatment with intravenous antibiotics\n8. Patient has a modified Rankin Score (mRS) of \\>4\n9. Clinically significant cardiovascular, digestive, respiratory, endocrine, or central nervous system disorders, previous mental disorders, or other disorders that may significantly affect the data collection or the ability to comply with the protocol per the investigator's discretion\n10. Known history of significant bleeding, coagulopathy, or Von Willebrand's disease\n11. Patient with an active cancer diagnosis and\u002For currently receiving treatment for cancer or has received treatment within the past 6 months\n12. Patient is currently receiving treatment or has been treated with anti-amyloid-beta monoclonal antibody therapy within the past 3 months\n13. Patient has contraindication for MRI or intrathecal administration of gadobutrol\n14. Currently enrolled in any other investigational clinical studies that the investigator believes may impact patient safety or study outcomes\n15. Patient is ineligible to participate for other reasons in the judgment of the investigator","50 Years",{"count":83,"type":21},15,[54],"The objective of this investigational device exemption (IDE) study is to evaluate the safety and feasibility of using the Symani System and microsurgical techniques in the deep cervical lymph node (dCLN) region in the setting of mild to moderate Alzheimer's disease and lymphatic abnormalities.",[87,88],"Alzheimer Disease","Lymphatic Obstruction","2026-06-01",{"date":91,"type":34},"2026-06-02",{"date":93,"type":34},"2026-04-30",{"date":95,"type":21},"2027-10-30",{"name":40,"class":41},2,{"id":99,"slug":4,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":52,"phases":101,"briefSummary":55,"conditions":102,"keywords":103,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":4},"100616919",{"count":51,"type":21},[54],[26,57,58,59,60],[62,63,64],"NOT_YET_RECRUITING","2026-03-27",{"date":107,"type":34},"2026-03-31",{"date":109,"type":21},"2026-04-28",{"date":111,"type":21},"2027-10-28",{"name":40,"class":41},{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":17,"minAge":121,"maxAge":122,"enrollmentInfo":123,"targetDuration":4,"studyType":52,"phases":125,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":72},"100582660","connect-a-multi-cohort-prospective-investigation-of-the-symani-surgical-system-100582660","NCT06866197","CONNECT: A Multi-Cohort, Prospective Investigation of the Symani® Surgical System","A Multi-Cohort, Prospective Investigation of the Symani® Surgical System: A Novel Approach to the Next Frontier of Microsurgery and Expanding Access to Care in Free Tissue Transfer and Lymphatic Surgery","CONNECT","Inclusion Criteria:\n\n* Adults, according to the local law\n* Patient agrees to participate in the study, return for all required follow-up visits, and has willingly provided written informed consent after receiving all information related to the study, its requirements, and the robotic assisted procedure\n* Patient with a clinical indication for a microsurgical anastomosis for a free flap transfer surgery and\u002For lymphatic surgery Investigator considers candidate acceptable for free flap transfer surgery and\u002For lymphatic surgery with a robotic assisted microsurgical anastomosis in accordance with the Symani System IFU\n\nInclusion Criteria for Therapeutic Lymphatic Patients:\n\n* For lymphedema of the extremities, swelling of lymphedema that is not completely reversed by decongestion therapy modalities. (Not applicable for patients with lymphedema of the head and neck)\n* For lymphedema of the extremities, at least one of the following positive quantitative measurements (not applicable for patients with lymphedema of the head and neck):\n\n  1. Volumetry differential between diseased limb and contralateral limb must be at least 10% of the other\n  2. Bioimpedance (L-Dex) differential, if feasible, between diseased limb and contralateral limb of at least 10 units\n* Maintain complete decongestive therapy (CDT), according to International Society of Lymphology (ISL) guidelines, for a minimum duration of four (4) weeks prior to screening\n* Willingness to comply with recommended regimen of self-care, with consistent use of compression garments from screening through the entire study duration\n* Patient must be diagnosed with Lymphedema\n* Patient must have a body mass index (BMI) of ≤ 35\n\nInclusion Criteria for Prophylactic Lymphatic Patients:\n\n* The patient has at least one identifiable risk factor for developing lymphedema of the extremities\n* Patient with a body mass index (BMI) of ≤ 35\n\nExclusion Criteria:\n\n* Patients who are not capable and\u002For unwilling to provide informed consent\n* Clinically significant cardiovascular, digestive, respiratory, endocrine, liver or central nervous system disorders, previous mental disorders, or other disorders that may significantly affect the data collection or the ability to comply with the protocol per the investigators discretion.\n* Known history of significant bleeding, coagulopathy, or Von Willebrand's disease\n* Patients with implanted pacemaker\n* Planned vein graft (either venous or arterial)\n* Previously documented history of chronic kidney disease (eGFR ≤ 30)\n* Currently enrolled in any other investigational clinical studies that the investigator believes may impact patient safety or outcomes\n* Patients belonging to vulnerable populations, such as pregnant women, or patients ineligible to participate for other reasons in the judgement of the investigator\n\nExclusion Criteria for Free Tissue Transfer Patients:\n\n* Patients with buried flaps\n* Multiple flaps planned for the procedure\n\nExclusion Criteria for Therapeutic Lymphatic Patients:\n\n* Patients with venous edema (arising from increased capillary filtration)\n* Patients with other medical conditions that could lead to acute limb edema, such as (but not limited to) acute venous thrombosis or heart failure\n* Current infection in the affected area of lymphedema\n* Current evidence of malignancy\n* Known iodine sensitivity\n* Patient's lymphatic disease is due to lipedema\n* Patients with bilateral lymphedema or lymphedema in multiple anatomical locations\n\nExclusion Criteria for Prophylactic Lymphatic Participants:\n\n* Patients for whom prophylactic surgery on more than one limb is planned\n* Known iodine sensitivity\n* Patients with post-thrombotic syndrome, arterial insufficiency, deep vein thrombosis or any other medical condition that could make them ineligible to participate in the judgment of the investigator\n* Patients diagnosed with lymphedema\n\nIntraoperative Exclusion Criteria:\n\n* Any presenting condition discovered intraoperatively that, in the opinion of the investigator, would make participating in this study not in the patient's best interest\n* The patient does not have at least two robotic sutures attempted during the index procedure","18 Years","100 Years",{"count":124,"type":21},180,[54],"The objective of this clinical study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during free tissue transfer surgery and lymphatic surgery.\n\nThe primary endpoints are:\n\nEffectiveness: Clinical Success, defined as intraoperative anastomosis patency. Safety: Freedom from device-related serious adverse events prior to discharge from the index hospitalization, as adjudicated by a Clinical Events Committee.\n\nParticipants will receive treatment as standard of care and be asked to:\n\nAllow the researchers to access and use their information. If participants are undergoing a therapeutic lymphatic procedure, they will be asked to complete a questionnaire and undergo lymphedema volume assessments as part of the study. If participants are undergoing a prophylactic lymphatic procedure, they will only be asked to undergo limb volume assessments.\n\nParticipants will be asked to comply with the follow-up visits as outlined in the protocol.",[28,26,27],{"date":129,"type":34},"2026-04-02",{"date":131,"type":34},"2026-01-20",{"date":133,"type":21},"2029-01-20",{"name":40,"class":41},{"id":136,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":138,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":143,"leadSponsor":144,"locationsCount":145},"100571805",{"count":20,"type":21},[25,26,27,28,29],"2026-03-04",{"date":141,"type":34},"2026-03-05",{"date":36,"type":34},{"date":38,"type":21},{"name":40,"class":41},4,{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":17,"minAge":121,"maxAge":154,"enrollmentInfo":155,"targetDuration":4,"studyType":52,"phases":157,"briefSummary":158,"conditions":159,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":72},"100599416","a-study-to-expand-the-use-of-symani-surgical-system-for-peripheral-nerve-repair-100599416","NCT07084207","A Study to Expand the Use of Symani® Surgical System for Peripheral Nerve Repair","REGEN: A Prospective, Randomized, Open Label Study to Expand the Use of Symani® Surgical System for Peripheral Nerve Repair","REGEN","Pre-Operative\n\nInclusion Criteria:\n\n1. Adults, at the time of nerve injury aged from 18 to 70 years\n2. Patient agrees to participate in the study, returns for all required follow-up visits, and has willingly provided written informed consent after receiving all information related to the study and its requirements\n3. Complete loss of a nerve-specific receptive field of the finger\n4. Patient with a clinical indication for a microsurgical nerve coaptation in nerve injury that can be repaired by end-to-end suturing\n5. Patient with traumatic transection of one or more digit nerves distal to the carpal tunnel with sensory autonomous innervation areas on the finger or thumb tips\n6. Investigator considers candidate acceptable for either conventional epineural suturing or robotic-assisted epineural suturing\n7. The injury was treated within 10 days\n\nExclusion Criteria:\n\n1. Patients who are not capable and\u002For unwilling to provide informed consent\n2. Clinically significant cardiovascular, digestive, respiratory, endocrine, liver or central nervous system disorders, previous mental disorders, or other disorders that may significantly affect the data collection or the ability to comply with the protocol per the investigators' discretion.\n3. Currently enrolled in any other investigational clinical studies that the investigator believes may impact patient safety or outcomes\n4. Patients belonging to vulnerable populations, such as pregnant women, or patients ineligible to participate for other reasons in the judgement of the investigator\n5. Indication for bilateral nerve repair\n6. Known impaired sensibility of the injured finger\n7. Patients with implanted pacemaker\n8. Replantation which includes bones\n\nIntra-Operative Inclusion Criteria\n\nIndividuals will be included in the study if the following criteria are met intraoperatively:\n\n1\\. Verification of a sensory nerve lesion without a gap and presence of a nerve that could be sutured in end-to-end fashion Intra-Operative Exclusion Criteria\n\nIndividuals will be excluded from participating in this study if any of the following criteria are met intraoperatively:\n\n1\\. Any presenting condition discovered intraoperatively that, in the opinion of the investigator, would","70 Years",{"count":156,"type":21},100,[54],"The objective of this study is to evaluate the Symani System's safety and effectiveness for microsurgical nerve coaptation, following nerve injuries to the hand.\n\nThis study will include participants with traumatic sensory nerve lesions of a finger nerve distal to the carpal tunnel who are treated with nerve suturing.\n\nThe primary effectiveness endpoint is the two-point discrimination (2PD) test, at 6-months post index procedure.\n\nThe primary safety endpoint is the intraoperative serious adverse event rate.",[160,161],"Nerve Injury","Peripheral Nerve Injuries","2026-01-30",{"date":164,"type":34},"2026-02-03",{"date":166,"type":34},"2025-12-18",{"date":168,"type":21},"2027-12-18",{"name":40,"class":41},{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":17,"minAge":121,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":52,"phases":180,"briefSummary":181,"conditions":182,"keywords":4,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":4},"100564364","a-global-prospective-real-world-investigation-of-the-symani-surgical-system-for-microsurgical-anastomosis-100564364","NCT06628219","A Global, Prospective, Real-World, Investigation of the Symani® Surgical System for Microsurgical Anastomosis","A Global, Prospective, Real-World, Investigation of the Symani® Surgical System for Microsurgical Anastomosis: Expanding Access to Care in Free Tissue Transfer Surgery and Lymphatic Surgery","PRIME","Inclusion Criteria:\n\n* Adults, according to the local law\n* Patient agrees to participate in the study, return for all required follow-up visits, and has willingly provided written informed consent after receiving all information related to the study, its requirements, and the robotic assisted procedure\n* Patient with a clinical indication for a microsurgical anastomosis for a free flap transfer surgery and\u002For lymphedema surgery\n* Investigator considers candidate acceptable for free flap transfer surgery and\u002For lymphatic surgery with a robotic assisted microsurgical anastomosis in accordance with the Symani System IFU\n\nInclusion Criteria for Therapeutic Lymphatic Patients:\n\n* For lymphedema of the extremities, swelling of lymphedema that is not completely reversed by decongestion therapy modalities. (Not applicable for patients with lymphedema of the head and neck)\n* For lymphedema of the extremities, at least one of the following positive quantitative measurements (not applicable for patients with lymphedema of the head and neck):\n\n  1. Volumetry differential between diseased limb and contralateral limb must be at least 10% of the other\n  2. Bioimpedance (L-Dex) differential, if feasible, between diseased limb and contralateral limb of at least 10 units\n* Completion of a full course of complete decongestive therapy (CDT), according to ISL guidelines at least 12 weeks prior to screening\n* Willingness to comply with recommended regimen of self-care, with consistent use of compression garments from screening through the entire study duration\n* Patient must be diagnosed with Lymphedema\n* Patient must have a body mass index (BMI) of ≤ 35\n\nInclusion Criteria for Prophylactic Lymphatic Patients:\n\n* In the opinion of the investigator, the patient has at least one identifiable indication for prophylactic lymphatic surgery.\n* Patient must have a body mass index (BMI) of ≤ 35\n\nExclusion Criteria:\n\n* Patients who are not capable and\u002For unwilling to provide informed consent\n* Clinically significant cardiovascular, digestive, respiratory, endocrine, liver or central nervous system disorders, previous mental disorders, or other disorders that may significantly affect the data collection or the ability to comply with the protocol per the investigators discretion.\n* Known history of significant bleeding, coagulopathy, or Von Willebrand's disease\n* Patients with implanted pacemaker\n* Planned vein graft (either venous or arterial)\n* Previously documented history of chronic kidney disease (eGFR ≤ 30)\n* Currently enrolled in any other investigational clinical studies that the investigator believes may impact patient safety or outcomes\n* Patients belonging to vulnerable populations, such as pregnant women, or patients ineligible to participate for other reasons in the judgement of the investigator\n\nExclusion Criteria for Free Tissue Transfer Patients:\n\n* Patients with buried flaps\n* Multiple flaps planned for the procedure\n\nExclusion Criteria for Therapeutic Lymphatic Patients:\n\n* Patients with venous edema (arising from increased capillary filtration)\n* Patients with other medical conditions that could lead to acute limb edema, such as (but not limited to) acute venous thrombosis or heart failure\n* Current infection in the affected area of lymphedema\n* Current evidence of malignancy\n* Known iodine sensitivity\n* Patient's lymphatic disease is due to lipedema\n* Patients with bilateral lymphedema or lymphedema in multiple anatomical locations\n\nExclusion Criteria for Prophylactic Lymphatic Participants:\n\n* Patients for whom prophylactic surgery on more than one limb is planned\n* Known iodine sensitivity\n* Patients with post-thrombotic syndrome, arterial insufficiency, deep vein thrombosis or any other medical condition that could make them ineligible to participate in the judgment of the investigator\n* Patients diagnosed with lymphedema\n* Patients who have received prior radiation therapy to the affected limb where the investigator believes the amount or extent of radiation could compromise the success of prophylactic lymphatic surgery\n\nIntraoperative Exclusion Criteria:\n\n* Any presenting condition discovered intraoperatively that, in the opinion of the investigator, would make participating in this study not in the patient's best interest\n* The patient does not have at least two robotic sutures attempted during the index procedure",{"count":179,"type":21},1000,[54],"The objective of this clinical study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during free tissue transfer surgery and lymphatic surgery.\n\nThe primary endpoints are:\n\n* Effectiveness: Clinical Success, defined as intraoperative anastomosis patency.\n* Safety: Freedom from device-related serious adverse events prior to discharge from the index hospitalization, as adjudicated by a Clinical Events Committee.\n\nParticipants will receive treatment as standard of care and be asked to:\n\n* Allow the researchers to access and use their information.\n* If participants are undergoing a therapeutic lymphatic procedure, they will be asked to complete a questionnaire and undergo lymphedema volume assessments as part of the study. If participants are undergoing a prophylactic lymphatic procedure, they will only be asked to undergo limb volume assessments.\n* Participants will be asked to comply with the follow-up visits as outlined in the protocol.",[25,26,27,28],"2024-12-05",{"date":185,"type":34},"2024-12-10",{"date":187,"type":21},"2025-02-01",{"date":189,"type":21},"2030-02-01",{"name":40,"class":41},""]