The DEXTER-assisted Non-Emergent and Acute cholecyStecTomy Study (The NEST Study)
Completed
- Conditions
- Cholecystectomy
- Registration Number
- NCT06473688
- 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 cholecystectomy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
Inclusion Criteria
- Aged > 18 years
- Patients planned to undergo elective robot-assisted and laparoscopic cholecystectomy; 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 30 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Universitätsklinikum Bonn
🇩🇪Bonn, Germany
Kantonsspital Winterthur
🇨🇭Winterthur, Switzerland
Groupe Hospitalier Saintes - Saint-Jean-d'Angély
🇫🇷Saintes, France
Klinik Hirslanden Zürich
🇨🇭Zürich, Switzerland