[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"free-tissue-transfer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:free-tissue-transfer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,69,79],{"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":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"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":54,"type":21},180,"INTERVENTIONAL",[57],"NA","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],"2026-03-27",{"date":62,"type":34},"2026-04-02",{"date":64,"type":34},"2026-01-20",{"date":66,"type":21},"2029-01-20",{"name":40,"class":41},1,{"id":70,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":72,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":77,"leadSponsor":78,"locationsCount":5},"100571805",{"count":20,"type":21},[25,26,27,28,29],"2026-03-04",{"date":75,"type":34},"2026-03-05",{"date":36,"type":34},{"date":38,"type":21},{"name":40,"class":41},{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":55,"phases":89,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"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":88,"type":21},1000,[57],"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],"NOT_YET_RECRUITING","2024-12-05",{"date":95,"type":34},"2024-12-10",{"date":97,"type":21},"2025-02-01",{"date":99,"type":21},"2030-02-01",{"name":40,"class":41}]