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

Launched by UNIVERSITY HOSPITAL, CLERMONT-FERRAND · Sep 28, 2023

Keywords

ClinConnect Summary

This clinical trial, called ENDORA2, is exploring the use of Augmented Reality (AR) technology during laparoscopic surgery for women who have benign tumors in the uterus, such as myomas or adenomyomas. AR allows surgeons to see virtual images on top of what they view through their instruments, which can help them locate and remove these tumors more easily and safely. The trial aims to find out if using this technology makes the surgery more comfortable for the surgeon and improves their ability to see the area they are working on.

To participate in this study, women between the ages of 18 and 84 who are scheduled for surgery to remove uterine tumors might be eligible. They need to have health insurance and agree to take part in the study after being fully informed about it. Participants can expect to undergo laparoscopic surgery with the added use of augmented reality tools. The trial is currently looking for volunteers, and it is important to note that certain individuals, such as those with specific medical conditions or those who cannot attend follow-ups, may not qualify for the study.

Gender

FEMALE

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).