Robotic Minimally Invasive Inguinal Hernia Repair With Dexter

Distalmotion SA3 sites in 3 countries50 target enrollmentJune 2, 2023

ConditionsInguinal Hernia Repair

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Inguinal Hernia Repair
Sponsor: Distalmotion SA
Enrollment: 50
Locations: 3
Primary Endpoint: Safety: occurrence of serious (Clavien - Dindo grades III-V), device-related, adverse events
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing primary transperitoneal unilateral or bilateral inguinal hernia repair.

Registry

clinicaltrials.gov

Start Date

June 2, 2023

End Date

October 23, 2023

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Distalmotion SA

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Aged \> 18 years
•Patients planned to undergo elective robot-assisted and laparoscopic surgery for primary unilateral or bilateral inguinal hernia repair using one camera port, two ports for the manipulating instruments, and additional ports as needed.
•Able to provide Informed Consent according to local regulation

Exclusion Criteria

•Morbidly obese patients (BMI \> 40)
•Any relative and absolute contraindications for the use of conventional endoscopes and endoscopic surgical instruments
•Need for robotic stapling, advanced energy delivery, ultrasound, cryoablation and microwave energy delivery
•Bleeding diathesis
•Pregnancy
•Patients with pacemakers or internal defibrillators
•Any planned concomitant procedures
•Patient deprived of liberty by administrative or judicial decision or under legal guardianship
•Participation in another interventional clinical trial