Clinical trial · Interventional
Evaluation of the Feasibility of Using Augmented Reality in Laparoscopic Surgery, by a Clinical Study During Gynecological Laparoscopic Surgical Procedures.
NCT06067971CI-TRIAL-00095059ENDORA2completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenomyoma of Uterus | — | UNRESOLVED | — |
| Myoma;Uterus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic surgery with augmented reality device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Laparoscopic surgery with the augmented reality device
- interventionNames
- Device: Laparoscopic surgery with augmented reality device
Primary outcomes (1)
- measure
- The feasibility of augmented reality will be measure using the SURG-TLX scale
- timeFrame
- In the intra-operative phase of the study
- description
- The feasibility of the technique will be considered satisfactory if the SURG-TLX score given by the surgeon at the end of the procedure is less than or equal to 33.7 (threshold defined by experts).
Secondary outcomes (8)
- measure
- Score of the surgeon's performance in using the augmented reality device
- timeFrame
- In the intra-operative phase of the study
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 84 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.