Robotic Minimally Invasive Ventral Hernia Repair With DEXTER

Recruiting

• Conditions: Ventral Hernia Repair

• Registration Number: NCT07071740
• Lead Sponsor: Distalmotion SA

Brief Summary

The aim of this clinical investigation is to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing incisional or primary ventral hernia repair.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-06-11
• Status Verified: 2025-07
• Study First Submitted: 2025-07-08
• Study First Submitted QC: 2025-07-08
• Last Update Submitted: 2025-07-08
• Study First Posted: 2025-07-17
• Last Update Posted: 2025-07-17
• Primary Completion: 2025-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Aged > 18 years
• Planned to undergo incisional and primary midline ventral (M2-M4; epigastric, umbilical and infraumbilical) hernia repair smaller and equal to 8cm
• Patient agrees to perform the 30-day follow-up assessment, as per standard of care

Exclusion Criteria

• Any planned concomitant procedures
• Active anticoagulant treatment
• Recurring hernia with mesh during primary hernia repair
• Need for transversal abdominal release
• Patients under corticosteroids or other immunosuppressive treatment
• Loss of domain type of hernia
• Previous incision extending from xiphoid process to pubic bone (= Median laparotomy M1 to M5)
• M2 hernia extending to M1 and/or M4 hernia extending to M5
• Ongoing intra-abdominal infection or septic state
• Abdominal fistulae
• History of major* abdominal or pelvic surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary safety 0utcome	up to 30 days after surgery	Occurrence of Clavien-Dindo grades III-V adverse events
Primary efficacy outcome	Intraoperative	Successful completion of the DEXTER-assisted procedure, i.e. free of any conversion to an open or fully laparoscopic surgical approach

Trial Locations

Locations (5)

Allgemein öffentliches Krankenhaus Spittal/Drau; 🇦🇹 Spittal An Der Drau, Austria

GH Saintes - Saint-Jean-d'Angély Site de Saintes; 🇫🇷 Saintes, France

Artemed Klinikum München Süd; 🇩🇪 München, Germany

Kantonsspital Winterthur; 🇨🇭 Winterthur, Switzerland

Hirslanden Klinik Zürich; 🇨🇭 Zürich, Switzerland