Robotic MIS With Dexter

Distalmotion SA100 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Hysterectomy Partial Nephrectomy Right Colectomy

Interventions

robotic-assisted surgeryDEVICE

Gynecology: robot-assisted and laparoscopic hysterectomy for benign or low risk malignant disease

robotic-assisted surgeryDEVICE

Urology: robot-assisted and laparoscopic partial nephrectomy

robotic-assisted surgeryDEVICE

General surgery: robot-assisted and laparoscopic right colectomy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

Hopital Paris Saint-Joseph

Paris, France

Centre Hospitalier de Saintes

Saintes, France

UKSH

Kiel, Germany

Inselspital

Bern, Switzerland

CHUV

Lausanne, Switzerland

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

Data from ClinicalTrials.gov

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