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

Primary Purpose

Myoma;Uterus, Adenomyoma of Uterus

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Laparoscopic surgery with augmented reality device
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Myoma;Uterus focused on measuring Augmented Reality, Laparoscopic surgery, Uterine myomectomy, Uterine adenomyomectomy, Hysterectomy, Minimally invasive surgery

Eligibility Criteria

18 Years - 84 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Polyclinique Urbain V
  • CHU Clermont-FerrandRecruiting
  • CHU de Saint-Étienne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Laparoscopic surgery with the augmented reality device

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
Collection of operative time
Collection of operating times for the entire surgery, as well as the various times associated with augmented reality device installation.
Number of device failures during surgery
Number of device failures during surgery (defined as an abrupt stop of the device during its use)
Number of failures to start up the software
Collection of the number of failures to set up the augmented reality device
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.
Number of laparoscopic/laparotomy conversions
Collection of the number of laparoscopic/laparotomy conversions.
Number of intraoperative and postoperative complications
Collection of the number of intraoperative and postoperative complications (especially vascular or ureteral wounds).
Quantification of bleeding
Collection of bleeding volume during the surgery.

Full Information

First Posted
September 28, 2023
Last Updated
September 28, 2023
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT06067971
Brief Title
Evaluation of the Feasibility of Using Augmented Reality in Laparoscopic Surgery, by a Clinical Study During Gynecological Laparoscopic Surgical Procedures. (ENDORA2)
Acronym
ENDORA2
Official Title
Evaluation of the Feasibility of Using Augmented Reality in Laparoscopic Surgery, by a Clinical Study During Gynecological Laparoscopic Surgical Procedures.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 29, 2023 (Actual)
Primary Completion Date
February 29, 2024 (Anticipated)
Study Completion Date
March 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myoma;Uterus, Adenomyoma of Uterus
Keywords
Augmented Reality, Laparoscopic surgery, Uterine myomectomy, Uterine adenomyomectomy, Hysterectomy, Minimally invasive surgery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise LACLAUTRE
Phone
334.73.754.963
Email
promo_interne_drci@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pauline CHAUVET
Organizational Affiliation
pchauvet@chu-clermontferrand.fr
Official's Role
Principal Investigator
Facility Information:
Facility Name
Polyclinique Urbain V
City
Avignon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise LACLAUTRE
First Name & Middle Initial & Last Name & Degree
Olivier DONNEZ
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise LACLAUTRE
First Name & Middle Initial & Last Name & Degree
Pauline CHAUVET
Facility Name
CHU de Saint-Étienne
City
Saint-Étienne
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise LACLAUTRE
First Name & Middle Initial & Last Name & Degree
Céline CHAULEUR

12. IPD Sharing Statement

Learn more about this trial

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

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