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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
NameTimeMethod
Primary safety outcomeup to 30 days after surgery

Occurrence of Clavien-Dindo grades III-V adverse events

Primary efficacy outcomeIntraoperative

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
NameTimeMethod

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, France
Alexis Vinet, MD
Contact
+33 2 54 29 60 07
Alexis.Vinet@ch-chateauroux.fr

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