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

Myoma;Uterus Clinical Trial

— ENDORA2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06067971
• Other study ID #: RBHP 2021 CHAUVET
• Secondary ID: 2021-A01987-34
• Status: Recruiting
• Phase: N/A
• Start date: March 29, 2023
• Est. completion date: March 29, 2024

Study information

• Verified date: September 2023
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise LACLAUTRE
• Phone: 334.73.754.963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 29, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 84 Years

Eligibility

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).

Related Conditions & MeSH terms

• Leiomyoma
• Myoma;Uterus

Intervention

Device:
• Laparoscopic surgery with augmented reality device
Gynecological laparoscopic surgery with augmented reality device.

Locations

Country	Name	City	State
France	Polyclinique Urbain V	Avignon
France	CHU Clermont-Ferrand	Clermont-Ferrand
France	CHU de Saint-Étienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The feasibility of augmented reality will be measure using the SURG-TLX scale	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).	In the intra-operative phase of the study
Secondary	Score of the surgeon's performance in using the augmented reality device	Measuring the performance-related score when using the augmented reality device by filling in a scale.	In the intra-operative phase of the study
Secondary	Collection of operative time	Collection of operating times for the entire surgery, as well as the various times associated with augmented reality device installation.	In the intra-operative phase of the study
Secondary	Number of device failures during surgery	Number of device failures during surgery (defined as an abrupt stop of the device during its use)	In the intra-operative phase of the study
Secondary	Number of failures to start up the software	Collection of the number of failures to set up the augmented reality device	In the intra-operative phase of the study
Secondary	Collection of the real direct medical costs of the procedure from an institutional point of view.	Collection of the real direct medical costs of the procedure from an institutional point of view.	From the date of the surgery to the date of the first post-operative visit, usually 1 month after the surgery
Secondary	Number of laparoscopic/laparotomy conversions	Collection of the number of laparoscopic/laparotomy conversions.	In the intra-operative phase of the study
Secondary	Number of intraoperative and postoperative complications	Collection of the number of intraoperative and postoperative complications (especially vascular or ureteral wounds).	From the date of the surgery to the date of the first post-operative visit, usually 1 month after the surgery
Secondary	Quantification of bleeding	Collection of bleeding volume during the surgery.	In the intra-operative phase of the study