Myoma;UterusENDORA2NCT06067971
Evaluation of the Feasibility of Using Augmented Reality in Laparoscopic Surgery, by a Clinical Study During Gynecological Laparoscopic Surgical Procedures.
A study testing Laparoscopic surgery with augmented reality device in people with Myoma;Uterus and Adenomyoma of Uterus, run by University Hospital, Clermont-Ferrand at 3 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 84 years, women only
- Conditions the study is for
- Myoma;Uterus, Adenomyoma of Uterus
- What is being tested?
- Laparoscopic surgery with augmented reality device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesFrance
- Study dates
- 29 Mar 2023to 15 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 84 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
3 sites in 1 country.
France3 sites
Polyclinique Urbain V
Avignon
CHU Clermont-Ferrand
Clermont-Ferrand
CHU de Saint-Étienne
Saint-Etienne
About this study
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
- Myoma;Uterus, Adenomyoma of Uterus
- Being tested
- Laparoscopic surgery with augmented reality device
- Keywords
- Augmented Reality, Laparoscopic surgery, Uterine myomectomy, Uterine adenomyomectomy, Hysterectomy, Minimally invasive surgery
- Medical subject headings
- Myofibroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic surgery with augmented reality deviceDevice
Gynecological laparoscopic surgery with augmented reality device.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic surgery with the augmented reality device | Experimental | Not described Receives: Device: Laparoscopic surgery with augmented reality device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: In the intra-operative phase of the study
Secondary outcomes (8)
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.
Measured: In the intra-operative phase of the study
Collection of operative time
Collection of operating times for the entire surgery, as well as the various times associated with augmented reality device installation.
Measured: In the intra-operative phase of the study
Number of device failures during surgery
Number of device failures during surgery (defined as an abrupt stop of the device during its use)
Measured: In the intra-operative phase of the study
Number of failures to start up the software
Collection of the number of failures to set up the augmented reality device
Measured: In the intra-operative phase of the study
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.
Measured: From the date of the surgery to the date of the first post-operative visit, usually 1 month after the surgery
Number of laparoscopic/laparotomy conversions
Collection of the number of laparoscopic/laparotomy conversions.
Measured: In the intra-operative phase of the study
Number of intraoperative and postoperative complications
Collection of the number of intraoperative and postoperative complications (especially vascular or ureteral wounds).
Measured: From the date of the surgery to the date of the first post-operative visit, usually 1 month after the surgery
Quantification of bleeding
Collection of bleeding volume during the surgery.
Measured: In the intra-operative phase of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start29 Mar 2023
- Primary completion16 Apr 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myoma;UterusStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pauline CHAUVET, Principal investigator, pchauvet@chu-clermontferrand.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067971
- Sponsor's protocol ID
- RBHP 2021 CHAUVET
- Other IDs
- 2021-A01987-34
- Acronym
- ENDORA2
- Status last verified
- Sep 2025
- First submitted
- 28 Sep 2023
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Feasibility of Using Augmented Reality in Laparoscopic Surgery, by a Clinical Study During Gynecological Laparoscopic Surgical Procedures.
- ClinicalTrials.gov ID
- NCT06067971
- Acronym / sponsor ID
- ENDORA2 / RBHP 2021 CHAUVET
- Conditions
- Myoma;Uterus, Adenomyoma of Uterus
- Keywords
- Augmented Reality, Laparoscopic surgery, Uterine myomectomy, Uterine adenomyomectomy, Hysterectomy, Minimally invasive surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 16 Apr 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 5 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic surgery with the augmented reality device | Experimental | Device: Laparoscopic surgery with augmented reality device |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic surgery with augmented reality deviceGynecological laparoscopic surgery with augmented reality device. | Device | Laparoscopic surgery with the augmented reality device |
Primary outcome
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).
8 secondary outcomes
Score of the surgeon's performance in using the augmented reality device
Time frame: In the intra-operative phase of the study
Collection of operative time
Time frame: In the intra-operative phase of the study
Number of device failures during surgery
Time frame: In the intra-operative phase of the study
Number of failures to start up the software
Time frame: In the intra-operative phase of the study
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
Number of laparoscopic/laparotomy conversions
Time frame: In the intra-operative phase of the study
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
Quantification of bleeding
Time frame: In the intra-operative phase of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
Related trials for Myoma;Uterus
Active, not recruiting
Prospective Study of TVRFA Treatment for FIGO Type 3-5 Uterine Fibroids
Leiomyoma (Uterine Fibroids)
RecruitingObservational study
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
Active, not recruiting
Life Study: Lifestyle Intervention in Fibroid Elimination
Uterine Fibroid
Not yet recruiting
Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
Uterine Polyps, Uterine Fibroids
RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
Uterine Fibroids, Hysterectomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pauline CHAUVET principal investigator
pchauvet@chu-clermontferrand.fr
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic surgery with augmented reality device in people with Myoma;Uterus and Adenomyoma of Uterus, run by University Hospital, Clermont-Ferrand at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The feasibility of augmented reality will be measure using the SURG-TLX scale (time frame: In the intra-operative phase of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.