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

Completed

• Conditions: Hysterectomy

• Registration Number: NCT06473675
• Lead Sponsor: Distalmotion SA

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 robotic-assisted and laparoscopic hysterectomy with adnexal surgery for benign disease.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-19
• Study First Submitted QC: 2024-06-19
• Study Start: 2024-06-20
• Study First Posted: 2024-06-25
• Primary Completion: 2025-04-02
• Study Completion: 2025-04-02
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 52

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
primary safety endpoint	up to 42 days	occurrence of Clavien - Dindo grades III-V adverse events
primary performance endpoint	intraoperative	successful completion of the Dexter-assisted procedure, i.e. free of any conversion to an open or fully laparoscopic surgical approach

Trial Locations

Locations (4)

Inselspital Bern; 🇨🇭 Bern, Switzerland

Spitäler FMI AG; 🇨🇭 Interlaken, Switzerland

Groupe Hospitalier Saintes - Saint-Jean-d'Angély; 🇫🇷 Saintes, France

Kantonsspital Baden; 🇨🇭 Baden, Switzerland