Robotic Minimally Invasive Gynecological, Urological, and General Surgery With Dexter

Distalmotion SA5 sites in 3 countries100 target enrollmentSeptember 27, 2022

ConditionsHysterectomy Partial Nephrectomy Right Colectomy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hysterectomy
Sponsor: Distalmotion SA
Enrollment: 100
Locations: 5
Primary Endpoint: occurrence of serious (Clavien - Dindo grades III-V), device related adverse events.
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to confirm the perioperative and early postoperative safety and clinical performance of the Dexter Robotic System (Dexter Surgical System, Model DM-L6).

Registry

clinicaltrials.gov

Start Date

September 27, 2022

End Date

January 9, 2025

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Distalmotion SA

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Aged ≥ 18 years
•Patient agrees to perform the 30-day follow-up assessment
•Able to provide signed Informed Consent, according to local regulation

Exclusion Criteria

•Morbidly obese patients.
•Any and all relative and absolute contraindications to endoscopic surgical technique applicable to the use of conventional endoscopic surgical instruments.
•Bleeding diathesis.
•Pregnancy.
•Patients with pacemakers or internal defibrillators.
•Any planned concomitant procedures.
•Patient deprived of liberty by administrative or judicial decision or under legal guardianship.
•Participation in another interventional clinical trial.

Outcomes

Primary Outcomes

occurrence of serious (Clavien - Dindo grades III-V), device related adverse events.

Time Frame: perioperatively up to 30 days

successful completion of the Dexter-assisted procedure, i.e. free of any device related permanent conversion to an open or fully laparoscopic surgical approach.

Time Frame: intraoperative