Robotic Assisted Right Colectomy With the DEXTER Robotic Surgery System
ConditionRight Colectomy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDistalmotion SA
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged > 18 years
Patient agrees to perform the 30-day follow-up assessment as per standard of care
Disqualifiers
History of radiotherapy on the target surgical area
Patients with distant metastasis
Any planned concomitant procedures
History of major abdominal surgery
Trial population
Adult patients undergoing a right colectomy for malignant or benign indication
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
right colectomy
DeviceRobotic-assisted right colectomy with the DEXTER robotic surgery system
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Primary safety outcome
Occurrence of Clavien-Dindo grades III-V adverse events
Time frame
up to 30 days after surgery2
Primary efficacy outcome
Successful completion of the Dexter-assisted procedure, i.e. free of any device related conversion to an open or fully laparoscopic surgical approach.
Time frame
IntraoperativeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Distalmotion SA
Lead sponsor
Confinis
Collaborator
Source ClinicalTrials.gov