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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
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
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