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

NCT06067971 | Completed

• 2 other identifiers: RBHP 2021 CHAUVET2021-A01987-34
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Myoma;Uterus; Adenomyoma of Uterus

Keywords

Augmented Reality; Laparoscopic surgery; Uterine myomectomy; Uterine adenomyomectomy; Hysterectomy; Minimally invasive surgery

Outcome Measures

Primary Outcomes (1)

• The feasibility of augmented reality will be measure using the SURG-TLX scale

  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 Outcomes (8)

• Score of the surgeon's performance in using the augmented reality device

  In the intra-operative phase of the study

• Collection of operative time

  In the intra-operative phase of the study

• Number of device failures during surgery

  In the intra-operative phase of the study

• Number of failures to start up the software

  In the intra-operative phase of the study

• 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

Study Arms (1)

Laparoscopic surgery with the augmented reality device

EXPERIMENTAL

Device: Laparoscopic surgery with augmented reality device

Interventions

Laparoscopic surgery with augmented reality device DEVICE

Gynecological laparoscopic surgery with augmented reality device.

Laparoscopic surgery with the augmented reality device

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (3)

Polyclinique Urbain V

Avignon, France

Location

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

CHU de Saint-Étienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Myofibroma

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Pauline CHAUVET

  pchauvet@chu-clermontferrand.fr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 5, 2023
• Study Start: March 29, 2023
• Primary Completion: April 16, 2025
• Study Completion: May 15, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

FR (3)