MedPath

Robotic MIS With Dexter

Completed
Conditions
Right Colectomy
Hysterectomy
Partial Nephrectomy
Registration Number
NCT05537727
Lead Sponsor
Distalmotion SA
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).

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
100
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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
occurrence of serious (Clavien - Dindo grades III-V), device related adverse events.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.intraoperative
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (5)

Hopital Paris Saint-Joseph

🇫🇷

Paris, France

Centre Hospitalier de Saintes

🇫🇷

Saintes, France

UKSH

🇩🇪

Kiel, Germany

Inselspital

🇨🇭

Bern, Switzerland

CHUV

🇨🇭

Lausanne, Switzerland

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