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

NCT ID: NCT06067971

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-29
• Study Completion Date: 2025-05-15

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Laparoscopic surgery with the augmented reality device

Group Type: EXPERIMENTAL

Laparoscopic surgery with augmented reality device

Intervention Type: DEVICE

Gynecological laparoscopic surgery with augmented reality device.

Interventions

Laparoscopic surgery with augmented reality device

Gynecological laparoscopic surgery with augmented reality device.

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pauline CHAUVET

Role: PRINCIPAL_INVESTIGATOR

pchauvet@chu-clermontferrand.fr

Locations

Polyclinique Urbain V

Avignon, , France

CHU Clermont-Ferrand

Clermont-Ferrand, , France

CHU de Saint-Étienne

Saint-Etienne, , France

Countries

France

Other Identifiers

2021-A01987-34

Identifier Type: OTHER

Identifier Source: secondary_id

RBHP 2021 CHAUVET

Identifier Type: -

Identifier Source: org_study_id