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RAS-Ahead: Robotic Minimally Invasive Inguinal Hernia Repair With Dexter

Sponsor
Distalmotion SA (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05873582
Collaborator
confinis AG (Other)
50
Enrollment
5.5
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Robotic-assisted inguinal hernia repair

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Robotic Minimally Invasive Inguinal Hernia Repair With Dexter
Anticipated Study Start Date :
May 18, 2023
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Oct 31, 2023

Outcome Measures

Primary Outcome Measures

  1. Safety: occurrence of serious (Clavien - Dindo grades III-V), device-related, adverse events [perioperatively up to 30 days]

  2. Performance: successful completion of the Dexter-assisted procedure, i.e. free of any conversion to an open or fully laparoscopic surgical approach [intraoperative]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Distalmotion SA
  • confinis AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Distalmotion SA
ClinicalTrials.gov Identifier:
NCT05873582
Other Study ID Numbers:
  • 2023-01
First Posted:
May 24, 2023
Last Update Posted:
May 25, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hernia
Hernia, Inguinal

Study Results

No Results Posted as of May 25, 2023