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

University Hospital, Clermont-Ferrand

Status

Completed

Conditions

Adenomyoma of Uterus

Myoma;Uterus

Treatments

Device: Laparoscopic surgery with augmented reality device

Study type

Interventional

Funder types

Other

Identifiers

NCT06067971

2021-A01987-34 (Other Identifier)

RBHP 2021 CHAUVET

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

Female

Ages

18 to 84 years old

Volunteers

No Healthy Volunteers

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).