Robotic MIS With Dexter

February 16, 2024 updated by: Distalmotion SA

Robotic Minimally Invasive Gynecological, Urological, and General Surgery 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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France
        • Completed
        • Hopital Paris Saint-Joseph
      • Saintes, France
        • Recruiting
        • Centre Hospitalier de Saintes
        • Contact:
          • Guillaume Hugues, MD
  • Germany
      • Kiel, Germany, 24105
        • Recruiting
        • UKSH
        • Contact:
          • Thomas Becker, MD
  • Switzerland
      • Bern, Switzerland, 3010
        • Completed
        • Inselspital
      • Lausanne, Switzerland, 1011
        • Recruiting
        • CHUV
        • Contact:
          • Dieter Hahnloser, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of the modified intent-to-treat (mITT) sample. This is defined as the set of patients who were enrolled in the trial and on whom robotic-assisted surgery with Dexter was at least started.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
occurrence of serious (Clavien - Dindo grades III-V), device related adverse events.
Time Frame: perioperatively up to 30 days
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
intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Distalmotion SA

Investigators

  • Principal Investigator: Dieter Hahnloser, MD, CHUV

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2022

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

September 8, 2022

First Submitted That Met QC Criteria

September 8, 2022

First Posted (Actual)

September 13, 2022

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2021-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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