Evaluation of the Feasibility of Using Augmented Reality in Laparoscopic Surgery, by a Clinical Study During Gynecological Laparoscopic Surgical Procedures. (ENDORA2)

September 8, 2025 updated by: University Hospital, Clermont-Ferrand
Augmented Reality is a technology that allows surgeons to superimpose virtual images from preoperative imaging onto the endoscopic vision system intraoperatively. The goal of this clinical trial is to demonstrate that the use of augmented reality during laparoscopic gynecological surgery with a dedicated device could provide assistance to the surgeon, in terms of technical comfort and better visualization of the benign tumor to be resected on a mobile organ.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • France
      • Avignon, France
        • Polyclinique Urbain V
      • Clermont-Ferrand, France
        • Chu Clermont-Ferrand
      • Saint-Etienne, France
        • CHU de Saint-Etienne

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged between 18 (included) and 84 (included),
  • Patient with intrauterine myoma, with indication for surgical management by laparoscopic myomectomy, or uterine pathology with indication for surgical management by laparoscopic hysterectomy,
  • Patient affiliated or beneficiary of a health insurance scheme,
  • Patient agreeing to participate in the study after having received the written information document and signed the consent form.

Exclusion Criteria:

  • Patients under 18 or over 84 years of age,
  • Patients with contraindications to MRI (pacemaker, ocular metal splinters, etc.),
  • Impossibility of planned surgery,
  • Patient with endometrial cancer contraindicating laparoscopic surgery,
  • Known pregnant or breast-feeding patient,
  • Patient of legal age, under guardianship or curatorship,
  • Patients whose regular follow-up is impossible for geographical, psychological, family or social reasons (these reasons will be collected).

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

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laparoscopic surgery with the augmented reality device
Device: Laparoscopic surgery with augmented reality device
Gynecological laparoscopic surgery with augmented reality device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The feasibility of augmented reality will be measure using the SURG-TLX scale
Time Frame: In the intra-operative phase of the study
The feasibility of the technique will be considered satisfactory if the SURG-TLX score given by the surgeon at the end of the procedure is less than or equal to 33.7 (threshold defined by experts).
In the intra-operative phase of the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score of the surgeon's performance in using the augmented reality device
Time Frame: In the intra-operative phase of the study
Measuring the performance-related score when using the augmented reality device by filling in a scale.
In the intra-operative phase of the study
Collection of operative time
Time Frame: In the intra-operative phase of the study
Collection of operating times for the entire surgery, as well as the various times associated with augmented reality device installation.
In the intra-operative phase of the study
Number of device failures during surgery
Time Frame: In the intra-operative phase of the study
Number of device failures during surgery (defined as an abrupt stop of the device during its use)
In the intra-operative phase of the study
Number of failures to start up the software
Time Frame: In the intra-operative phase of the study
Collection of the number of failures to set up the augmented reality device
In the intra-operative phase of the study
Collection of the real direct medical costs of the procedure from an institutional point of view.
Time Frame: From the date of the surgery to the date of the first post-operative visit, usually 1 month after the surgery
Collection of the real direct medical costs of the procedure from an institutional point of view.
From the date of the surgery to the date of the first post-operative visit, usually 1 month after the surgery
Number of laparoscopic/laparotomy conversions
Time Frame: In the intra-operative phase of the study
Collection of the number of laparoscopic/laparotomy conversions.
In the intra-operative phase of the study
Number of intraoperative and postoperative complications
Time Frame: From the date of the surgery to the date of the first post-operative visit, usually 1 month after the surgery
Collection of the number of intraoperative and postoperative complications (especially vascular or ureteral wounds).
From the date of the surgery to the date of the first post-operative visit, usually 1 month after the surgery
Quantification of bleeding
Time Frame: In the intra-operative phase of the study
Collection of bleeding volume during the surgery.
In the intra-operative phase of the study

Collaborators and Investigators

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

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Pauline CHAUVET, pchauvet@chu-clermontferrand.fr

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)

March 29, 2023

Primary Completion (Actual)

April 16, 2025

Study Completion (Actual)

May 15, 2025

Study Registration Dates

First Submitted

September 28, 2023

First Submitted That Met QC Criteria

September 28, 2023

First Posted (Actual)

October 5, 2023

Study Record Updates

Last Update Posted (Estimated)

September 12, 2025

Last Update Submitted That Met QC Criteria

September 8, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RBHP 2021 CHAUVET
  • 2021-A01987-34 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Myoma;Uterus

Clinical Trials on Laparoscopic surgery with augmented reality device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe