Using augmented reality to assist in laparoscopic gynecological surgeries
Evaluation of the Feasibility of Using Augmented Reality in Laparoscopic Surgery, by a Clinical Study During Gynecological Laparoscopic Surgical Procedures.
NA · University Hospital, Clermont-Ferrand · NCT06067971
This study is testing if using augmented reality during laparoscopic surgeries can help doctors see better and perform procedures more easily for patients with conditions like uterine fibroids.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 84 Years |
| Sex | Female |
| Sponsor | University Hospital, Clermont-Ferrand (other) |
| Locations | 3 sites (Avignon and 2 other locations) |
| Trial ID | NCT06067971 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the feasibility of using augmented reality technology during laparoscopic surgeries for conditions like uterine myoma and adenomyoma. By superimposing virtual images from preoperative imaging onto the surgeon's view, the study aims to enhance visualization and technical comfort during procedures such as myomectomy and hysterectomy. The trial will involve patients aged 18 to 84 who require surgical management for these conditions, and it will assess the effectiveness of this innovative approach in improving surgical outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18 to 84 with intrauterine myoma or other uterine pathologies requiring laparoscopic surgery.
Not a fit: Patients with contraindications to MRI, endometrial cancer, or those unable to undergo planned surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical precision and outcomes for patients undergoing laparoscopic procedures.
How similar studies have performed: While augmented reality in surgery is a growing field, this specific application in gynecological laparoscopic procedures is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Avignon and 2 other locations
- Polyclinique Urbain V — Avignon, France (RECRUITING)
- CHU Clermont-Ferrand — Clermont-Ferrand, France (RECRUITING)
- CHU de Saint-Étienne — Saint-Étienne, France (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Pauline CHAUVET — pchauvet@chu-clermontferrand.fr
- Study coordinator: Lise LACLAUTRE
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: 334.73.754.963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Myoma, Uterus, Adenomyoma of Uterus, Augmented Reality, Laparoscopic surgery, Uterine myomectomy, Uterine adenomyomectomy, Hysterectomy