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OpenTrials
Completed

NCT Number: NCT06067971

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

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.

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Key information

Conditions

Myoma;Uterus Adenomyoma of Uterus Connective Tissue Diseases Myofibroma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Skin and Connective Tissue Diseases

Age range

18 year–84 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Polyclinique Urbain V, Avignon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Laparoscopic surgery with augmented reality device

Device

Gynecological laparoscopic surgery with augmented reality device.

Primary outcomes

  1. The feasibility of augmented reality will be measure using the SURG-TLX scale

    Time frame: In the intra-operative phase of the study

    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

  1. Score of the surgeon's performance in using the augmented reality device

    Time frame: In the intra-operative phase of the study

    Measuring the performance-related score when using the augmented reality device by filling in a scale.

  2. Collection of operative time

    Time frame: In the intra-operative phase of the study

    Collection of operating times for the entire surgery, as well as the various times associated with augmented reality device installation.

  3. Number of device failures during surgery

    Time frame: In the intra-operative phase of the study

    Number of device failures during surgery (defined as an abrupt stop of the device during its use)

  4. Number of failures to start up the software

    Time frame: In the intra-operative phase of the study

    Collection of the number of failures to set up the augmented reality device

  5. 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

    Collection of the real direct medical costs of the procedure from an institutional point of view.

  6. Number of laparoscopic/laparotomy conversions

    Time frame: In the intra-operative phase of the study

    Collection of the number of laparoscopic/laparotomy conversions.

  7. Number of intraoperative and postoperative complications

    Time frame: From the date of the surgery to the date of the first post-operative visit, usually 1 month after the surgery

    Collection of the number of intraoperative and postoperative complications (especially vascular or ureteral wounds).

  8. Quantification of bleeding

    Time frame: In the intra-operative phase of the study

    Collection of bleeding volume during the surgery.

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: ENDORA2

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 5, 2023
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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