Robotic Assisted Right Colectomy With the DEXTER Robotic Surgery System
Recruiting
- Conditions
- Right Colectomy
- Registration Number
- NCT07123051
- 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 right colectomy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 33
Inclusion Criteria
- Aged > 18 years
- Patient agrees to perform the 30-day follow-up assessment as per standard of care
Exclusion Criteria
- History of radiotherapy on the target surgical area
- Patients with distant metastasis
- Any planned concomitant procedures
- History of major abdominal surgery
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary safety outcome up to 30 days after surgery Occurrence of Clavien-Dindo grades III-V adverse events
Primary efficacy outcome Intraoperative Successful completion of the Dexter-assisted procedure, i.e. free of any device related conversion to an open or fully laparoscopic surgical approach.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
CH Châteauroux - Le Blanc
🇫🇷Châteauroux, France
Groupe Hospitalier Saintes - Saint-Jean-d'Angély, Saintes
🇫🇷Saintes, France
Artemed Klinikum München Süd
🇩🇪Munich, Germany
CH Châteauroux - Le Blanc🇫🇷Châteauroux, FranceAlexis Vinet, MDContact+33 2 54 29 60 07Alexis.Vinet@ch-chateauroux.fr