[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07181876":3,"trial-entities:NCT07181876":87,"trial-summary:NCT07181876":91},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":16,"phases":21,"enrollment_info":22,"interventions":25,"primary_outcomes":30,"secondary_outcomes":39,"sex":40,"minimum_age":41,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":42,"std_ages":52,"locations":55,"central_contacts":79,"overall_officials":84,"references":85,"see_also_links":86},"NCT07181876","2025-03","Robotic Minimally Invasive Inguinal Hernia Repair Post-Market Clinical Study With the DEXTER Robotic System","RECRUITING","2029-12","2026-07","2026-07-06","2025-11-26","Distalmotion SA","INDUSTRY",false,"The purpose of this post-market, observational study is to collect data under anticipated conditions of use that demonstrates that DEXTER performs as intended in the intended patient population, including a variety of representative disease etiologies and demographic groups.",null,[18],"Inguinal Hernia Repair",[],"OBSERVATIONAL",[],{"count":23,"type":24},140,"ESTIMATED",[26],{"type":27,"name":28,"description":29},"DEVICE","inguinal hernia repair","Robotic-assisted inguinal hernia repair with the DEXTER robotic surgery system",[31,35],{"measure":32,"description":33,"timeFrame":34},"Primary safety outcome","Occurrence of Clavien-Dindo grades III-V adverse events","up to 30 days after surgery",{"measure":36,"description":37,"timeFrame":38},"Primary efficacy outcome","Successful completion of the DEXTER-assisted procedure, i.e. free of any conversion to an open or fully laparoscopic surgical approach","Intraoperative",[],"ALL","22 Years",{"inclusion":43,"exclusion":47,"raw_text":51},[44,45,46],"Subject is ≥ 22 years of age at time of enrollment\u002Fconsent","Subject is indicated for and planned to undergo robot-assisted and laparoscopic surgery for unilateral or bilateral inguinal hernia repair","Subject is able and willing to comply with the protocol requirements, has been informed of the nature of the study, and has signed the IRB-approved informed consent form",[48,49,50],"Subject with any relative and absolute contraindications for the use of conventional endoscopes and endoscopic surgical instruments and\u002For general non-procedure specific contraindications to endoscopic surgery including bleeding diathesis and pregnancy","Subject is participating in another clinical investigation at the time of enrollment or planned participation at any time during this clinical study","Subject has a known or suspected medical condition that, in the opinion of the Investigator, may put the subject at risk for participation in this clinical study","Inclusion Criteria:\n\n* Subject is ≥ 22 years of age at time of enrollment\u002Fconsent\n* Subject is indicated for and planned to undergo robot-assisted and laparoscopic surgery for unilateral or bilateral inguinal hernia repair\n* Subject is able and willing to comply with the protocol requirements, has been informed of the nature of the study, and has signed the IRB-approved informed consent form\n\nExclusion Criteria:\n\n* Subject with any relative and absolute contraindications for the use of conventional endoscopes and endoscopic surgical instruments and\u002For general non-procedure specific contraindications to endoscopic surgery including bleeding diathesis and pregnancy\n* Subject is participating in another clinical investigation at the time of enrollment or planned participation at any time during this clinical study\n* Subject has a known or suspected medical condition that, in the opinion of the Investigator, may put the subject at risk for participation in this clinical study",[53,54],"ADULT","OLDER_ADULT",[56,65],{"facility":57,"status":7,"city":58,"state":59,"zip":60,"country":61,"geoPoint":62},"Northtowns Ambulatory Surgical Center (NASC)","Buffalo","New York","14221","United States",{"lat":63,"lon":64},42.88645,-78.87837,{"facility":66,"status":7,"city":67,"state":68,"zip":69,"country":61,"contacts":70,"geoPoint":76},"Memorial Hermann-Texas Medical Center - UT Health Houston","Houston","Texas","77030",[71],{"name":72,"role":73,"phone":74,"email":75},"Jonah Stulberg, MD","CONTACT","+1 (713) 486-1330","jonha.j.stulberg@uth.tmc.edu",{"lat":77,"lon":78},29.76328,-95.36327,[80],{"name":81,"role":73,"phone":82,"email":83},"Pascal Lehmann","+41215105890","pascal.lehmann@distalmotion.com",[],[],[],{"nct_id":4,"conditions":88,"biomarkers":90},[89],"Inguinal Hernia",[],{"nct_id":4,"found":92,"summary":93,"prompt_version":103},true,{"design":94,"status":95,"heading":96,"summary":97,"follow_up":98,"word_count":99,"commitments":100,"compensation":101,"drugs_mentioned":102},"This is an observational study, meaning researchers will watch and collect data without assigning treatments. It aims to enroll 140 participants.","completed","Observational Study of Robotic Minimally Invasive Inguinal Hernia Repair with DEXTER Robotic System","This observational study is looking at how well the DEXTER robotic surgery system works for minimally invasive inguinal hernia repair (a surgery to fix a bulge in your groin area). The study aims to collect information on how the DEXTER system performs in real-world use for people needing this type of hernia repair. You may be able to join if you are at least 22 years old and are scheduled to have robot-assisted or laparoscopic surgery for an inguinal hernia. Researchers will look at the safety of the DEXTER system up to 30 days after surgery and how effective it is during the operation itself. The current status of this study is unclear, and it plans to enroll 140 participants.","Participants will be followed for safety outcomes for up to 30 days after surgery.",120,"Not specified in the trial record.","Not stated in the trial record.",[28],"v2"]