Robotic Minimally Invasive Ventral Hernia Repair With DEXTER (RAVEN)

Distalmotion

Status: Completed

Conditions: Ventral Hernia Repair

Treatments: Device: ventral hernia repair

Study type: Observational

Funder types: Industry

Identifiers

NCT07071740

2025-02

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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