Robotic Minimally Invasive Inguinal Hernia Repair With Dexter

Last updated: January 3, 2024
Sponsor: Distalmotion SA
Overall Status: Completed

Phase

N/A

Condition

Hernia

Treatment

Robotic-assisted inguinal hernia repair

Clinical Study ID

NCT05873582
2023-01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Morbidly obese patients (BMI > 40)
  • Any relative and absolute contraindications for the use of conventional endoscopes andendoscopic surgical instruments
  • Need for robotic stapling, advanced energy delivery, ultrasound, cryoablation andmicrowave 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 legalguardianship
  • Participation in another interventional clinical trial

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Robotic-assisted inguinal hernia repair
Phase:
Study Start date:
June 02, 2023
Estimated Completion Date:
October 23, 2023

Connect with a study center

  • Centre Hospitalier de Saintes

    Saintes,
    France

    Site Not Available

  • UKSH Kiel

    Kiel, 24105
    Germany

    Site Not Available

  • Kantonspital Winterthur

    Winterthur,
    Switzerland

    Site Not Available

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