[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599416":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":11,"centralContacts":33,"locations":39,"responsibleParty":57,"collaborators":11,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":11,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":11,"overallStatus":42,"whyStopped":11,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"MMI (Medical Microinstruments, Inc.)","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Robotic-Assisted Surgery (RAS) group","ACTIVE_COMPARATOR",null,[13],"Device: Symani® Surgical System",{"label":15,"type":10,"description":11,"interventionNames":16},"Manual Surgery (MS) group",[17],"Procedure: Manual Surgery",[19,26],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Symani® Surgical System","Robotic-assisted surgery consists of participants who undergo nerve coaptation with the Symani Surgical System, according to the Instruction for Use (IFU). In order for the surgery to be considered a robotic assisted surgery, the participants must be randomized to the RAS group which will include:\n\n* Participants where all nerve coaptations were performed entirely with Symani.\n* Participants who underwent a hybrid procedure, where a coaptation was commenced using Symani but a switch to manual suturing occurred during the procedure",[9],[25],"RAS",{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"PROCEDURE","Manual Surgery","Manual surgery consists of participants who undergo nerve coaptation through manual techniques by a surgeon using handheld instruments without robotic assistance. In order for the surgery to be considered a manual surgery, the participants must be randomized to the MS group which will include:\n\n* Participants where all nerve coaptations were performed entirely manually.\n* Participants who underwent a hybrid procedure, where a coaptation was commenced using manual suturing but a switch to Symani occurred during the procedure.",[15],[32],"MS",[34],{"name":35,"role":36,"phone":37,"phoneExt":11,"email":38},"Clinical Operations","CONTACT","8336646276","clinical.ops@mmimicro.com",[40],{"facility":41,"status":42,"city":43,"state":11,"zip":11,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"BG Klinik Ludwigshafen","RECRUITING","Ludwigshafen","Germany","DE",{"type":47,"coordinates":48},"Point",[49,50],9.06138,47.81663,{"lat":50,"lon":49},[53,55],{"name":54,"role":36,"phone":11,"phoneExt":11,"email":11},"Arne Böcker",{"name":54,"role":56,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"type":58,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100599416","a-study-to-expand-the-use-of-symani-surgical-system-for-peripheral-nerve-repair-100599416",false,"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","ALL","18 Years","70 Years",{"count":71,"type":72},100,"ESTIMATED","INTERVENTIONAL",[75],"NA","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.",[78,79],"Nerve Injury","Peripheral Nerve Injuries","2026-01-30",{"date":82,"type":83},"2026-02-03","ACTUAL",{"date":85,"type":83},"2025-12-18",{"date":87,"type":72},"2027-12-18",{"name":5,"class":6},1]