Hysterectomy With Adnexal Surgery Procedures With the DEXTER Robotic System (The HYPER Study)
- Conditions
- Hysterectomy
- Registration Number
- NCT06473675
- Lead Sponsor
- Distalmotion SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 50
Inclusion Criteria:<br><br> - Aged > 18 years<br><br> - Patients planned to undergo elective robot-assisted and laparoscopic hysterectomy<br> with adnexal surgery for benign disease; using one camera port, two ports for the<br> manipulating instruments, and additional ports as needed.<br><br>Exclusion Criteria:<br><br> - Morbidly obese patients (BMI > 40)<br><br> - Any relative and absolute contraindications for the use of conventional endoscopes<br> and endoscopic surgical instruments<br><br> - Need for robotic stapling, advanced energy delivery, ultrasound, cryoablation and<br> microwave energy delivery<br><br> - Bleeding diathesis<br><br> - Pregnancy<br><br> - Patients with pacemakers or internal defibrillators<br><br> - Any planned concomitant procedures<br><br> - Patient deprived of liberty by administrative or judicial decision.<br><br> - Participation in another interventional clinical trial
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method primary safety endpoint;primary performance endpoint
- Secondary Outcome Measures
Name Time Method