NCT07123051RecruitingNot Applicable
Robotic Assisted Right Colectomy With the DEXTER Robotic Surgery System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Distalmotion SA
- Enrollment
- 33
- Locations
- 7
- Primary Endpoint
- Primary safety outcome
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Primary safety outcome
Time Frame: up to 30 days after surgery
Occurrence of Clavien-Dindo grades III-V adverse events
Primary efficacy outcome
Time Frame: 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 Outcomes
No secondary outcomes reported
Investigators
Study Sites (7)
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