Skip to main content
OpenTrials
Completed

NCT Number: NCT05537727

Robotic MIS With Dexter

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hysterectomy Partial Nephrectomy Right Colectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Paris Saint-Joseph, Paris, France

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Robotic-assisted Surgery

Device

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

Primary outcomes

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

    Time frame: perioperatively up to 30 days

  2. 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

Sponsors and collaborators

Lead sponsor

Distalmotion SA

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 13, 2022
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.