CompletedNot Applicable

Hysterectomy With Adnexal Surgery Procedures With the DEXTER Robotic System (The HYPER Study)

France, Switzerland52 participantsStarted 2024-06-20

Plain-language summary

This study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing robotic-assisted and laparoscopic hysterectomy with adnexal surgery for benign disease.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Aged \> 18 years * Patients planned to undergo elective robot-assisted and laparoscopic hysterectomy with adnexal surgery for benign disease; using one camera port, two ports for the manipulating instruments, and additional ports as needed. 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. * Participation in another interventional clinical trial

What they're measuring

primary safety endpoint

Timeframe: up to 42 days

primary performance endpoint

Timeframe: intraoperative

Trial details

NCT IDNCT06473675

SponsorDistalmotion SA

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-04-02

View on ClinicalTrials.gov More Hysterectomy trials