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Trial Title:
Evaluation of the Feasibility of Using Augmented Reality in Laparoscopic Surgery, by a Clinical Study During Gynecological Laparoscopic Surgical Procedures. (ENDORA2)
NCT ID:
NCT06067971
Condition:
Myoma;Uterus
Adenomyoma of Uterus
Conditions: Official terms:
Leiomyoma
Myofibroma
Adenomyoma
Conditions: Keywords:
Augmented Reality
Laparoscopic surgery
Uterine myomectomy
Uterine adenomyomectomy
Hysterectomy
Minimally invasive surgery
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Laparoscopic surgery with augmented reality device
Description:
Gynecological laparoscopic surgery with augmented reality device.
Arm group label:
Laparoscopic surgery with the augmented reality device
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.
Criteria for 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).
Gender:
Female
Minimum age:
18 Years
Maximum age:
84 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Polyclinique Urbain V
Address:
City:
Avignon
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Lise LACLAUTRE
Investigator:
Last name:
Olivier DONNEZ
Email:
Principal Investigator
Facility:
Name:
CHU Clermont-Ferrand
Address:
City:
Clermont-Ferrand
Country:
France
Status:
Recruiting
Contact:
Last name:
Lise LACLAUTRE
Investigator:
Last name:
Pauline CHAUVET
Email:
Principal Investigator
Facility:
Name:
CHU de Saint-Étienne
Address:
City:
Saint-Étienne
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Lise LACLAUTRE
Investigator:
Last name:
Céline CHAULEUR
Email:
Principal Investigator
Start date:
March 29, 2023
Completion date:
March 29, 2024
Lead sponsor:
Agency:
University Hospital, Clermont-Ferrand
Agency class:
Other
Source:
University Hospital, Clermont-Ferrand
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06067971
