AzTrials
AzTrials

EndometriosisEndomercyoNCT06356831

National Registry of Surgical Treatment and Percutaneous Cryoablation of Parietal Endometriosis

An observational study of Endometriosis and Cryotherapy Effect, run by Centre Hospitalier Intercommunal Creteil at 18 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

National multicentric registry of a cohort of patient with suffering parietal endometriosis, carried out by a multidisciplinary radiosurgery team Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometriosis, Cryotherapy Effect, Surgical
How many people
300 participants
Where
18 sitesFrance
Study dates
15 Jun 2024to 31 Jan 2028
How long will I take part?
3 Years
Phase
Observational
Are there results?
Not yet: the study is under way

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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: patient with endomecriosis at least 18 years of age who will be oer are treate by cryo ablation or surgical treatement

Who may be able to join

  • Presence of parietal endometriosis: with suggestive clinical and imaging criteria (MRI and ultrasound)
  • Symptomatic parietal endometriosis (VAS > 3 OR bothersome bleeding OR reported impact on quality of life)

Who cannot join

  • Endometriosis not affecting the anterior wall of the abdomen (as deep pelvic muscle: ilio-psoas, obturators, perineal, ischio-anal fossa)
  • Minor patient (< 18 years)
  • Pregnant patient at any trimester
  • Patient with hemostasis disorders (constitutional or acquired)
  • Patient with systemic infection or localized scar infection upon inclusion.
  • Patient with contraindications to MRI
Show all 11Show fewer
  • Female patient with a planned medical or surgical procedure for the duration of the study that may interfere with the proper conduct of the study.
  • Patient unable to understand the information provided
  • Patient who is not affiliated to the social security system
  • Patient under curatorship or tutorship
  • Patient with a nodule of primary or secondary malignant tumor origin

Trial locations and contacts

18 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Léo Razakamanantsoa, Dr contact

0157023567

Leo.Razakamanantsoa@chicreteil.fr

18 sites in 1 country

France18 sites, 15 recruiting

  • CHU bordeaux

    Bordeau

    Clément MARCELIN, Dr, 05 56 79 56 79, Clement.marcelin@chu-bordeaux.fr

    Jean-Luc BRUN, Dr, 05 56 79 59 85, Jean-luc.brun@chu-bordeaux.fr

    Recruiting

  • Clinique Tivoli

    Bordeaux

    Horace ROMAN, Pr, 05 56 52 52 53, Horace.roman@gmail.com

    Recruiting

  • CHU Clermont Ferrand

    Clermont-Ferrand

    Benoit Chauveau, Dr, 04 73 75 07 50, b_chauveau@chu-clermontferrand.fr

    Michel CANIS, Dr, 04 73 31 60 53., mcanis@chu-clermontferrand.fr

    Recruiting

  • CHI Creteil

    Créteil

    Leo RAZAKAMANANTSOA, Dr, 0157023567, leo.razakamanantsoa@chicreteil.fr

    Yann SALHI, Dr, yann.salhi@chicreteil.fr

    Recruiting

  • Lyon Hôpital La Croix Rousse

    Lyon

    Audrey HAQUIN, Dr, 04 72 07 15 07, audrey.haquin@chu-lyon.fr

    Gil DUBERNARD, gil.dubernard@chu-lyon.fr

    Recruiting

  • Lyon Hôpital Sud

    Lyon

    Alexandre GALAN, Dr, 04 78 86 51 15, alexandre.galant@chu-lyon.fr

    Pierre A BOLZE, pierre-adrien.bolze@chu-lyon.fr

    Recruiting

  • Lyon Louis Pradel

    Lyon

    Active, not recruiting

  • APHM-Hôpital Nord

    Marseille

    Active, not recruiting

  • APHP-Hôpital la Conception La Timone

    Marseille

    Lisa CALDERON, lisa.calderon@ap-hm.fr

    Aubert AGOSTINI, Pr, 0491383702, aubert.agostini@ap-hm.fr

    Recruiting

  • CHU Montpellier

    Montpellier

    Cécile VERHEYDEN, Dr, 0467336733, c-verheyden@chu-montpellier.fr

    Claire VINCENS, Dr, c-vincens@chu-montpellier.fr

    Recruiting

  • CHU Nime

    Nîmes

    Julien FRANDON, Dr, 04 66 76 60 63, JULIEN.FRANDON@chu-nimes.fr

    Recruiting

  • AP-HP - Tenon

    Paris

    Alexis Nobileau, Dr, 01 56 01 70 88, alexis.nobileau@aphp.fr

    Yohann DABI, Yohann.dabi@aphp.fr

    Recruiting

  • AP-HP Hôpital Européen Georges Pompidou

    Paris

    Tom BOEKEN, Dr, 01 56 09 23 20, tom.boeken@aphp.fr

    Henri AZAIS, Dr, henri.azais@aphp.fr

    Recruiting

  • APHP Cochin-Port Royal

    Paris

    Maxime BARAT, Dr, 01 58 41 41 41, maxime.barat@aphp.fr

    Anthony DOHAN, Pr

    Recruiting

  • APHP-La Pitié

    Paris

    Charles Roux, Dr, 0142165530, charles.roux@aphp.fr

    Geoffroy Canlorbe, geoffroy.canlorbe@aphp.fr

    Recruiting

  • CHU Strasbourg

    Strasbourg

    Enrolling by invitation

  • CHU Toulouse

    Toulouse

    Active, not recruiting

  • CH Valencienne

    Valenciennes

    Thibault POCLET, Dr, 0327143333, Poclet-t@ch-valenciennes.fr

    Recruiting

Other trials in France

About this study

National multicentric registry of a cohort of patient with suffering parietal endometriosis, carried out by a multidisciplinary radiosurgery team

Read the detailed description

Patient who suffering of parietal endometriosis treat by cryoablation or chirurgical will be recorded in national registry. the patient will be follow during 3 years after treatement.

Keywords
endometriosis, Cryo ablation, Surgical operation, radiology
Medical subject headings
Endometriosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. creation of a national registry for the removal of nodules by cryoablation or surgery for parietal endometriosis

    number of Endometriosis 's patient treat by cryoablation or surgical

    Measured: at inclusion

Secondary outcomes (15)

  1. Characterize the epidemiology of parietal endometriosis nodules

    average of parietal endometriosis nodules

    Measured: at 1 month, 6month 1year 2 years and 3 years after treatmeant

  2. Characterize the epidemiology of parietal endometriosis nodules

    average of parietal endometriosis nodules

    Measured: at inclusion

  3. To assess the impact of hormone treatment on parietal endometriosis

    number of hormone treatment on parietal endometriosis

    Measured: at 1 month, 6month 1year 2 years and 3 years after treatmeant

  4. Assess the demographic distribution of parietal endometriosis

    compare the size of of endometriosis nodules pre- and post-treatment

    Measured: At inclusion

  5. Evaluate pre- and post-treatment imaging characteristics of parietal endometriosis

    compare the size of of endometriosis nodules pre- and post-treatment

    Measured: through study completion average 3 years

  6. Evaluate the aesthetic impact of the treatments

    number of complication

    Measured: at 1 month after treatmeant

  7. Assess the complication rate between the two groups

    number of complication between the two groups

    Measured: at 1 month, 6month 1year 2 years and 3 years after treatmeant

  8. Assess the Severity of Complications according to Society (SIR) of Interventional Radiology or Cardiovascular and Interventional Radiological Society of Europe ( CIRSE) for Radiologists

    average of Complications according to SIR or CIRSE for Radiologists

    Measured: at inclusion

  9. Assess the Severity of Complications according to Clavien Dindo for the surgeon

    average of Complications according to Clavien Dindo for the surgeon

    Measured: at inclusion

  10. Assess the recidivism rate at 3 years

    number of recidivism at 3 years

    Measured: at 3 years

  11. Assess the quality of life between the two groups with PGIC-7 questionnaire

    average Patient Global Impression of Change PGIC-7 score : PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."

    Measured: at inclusion,1 month, 6 months 1year 2 years and 3 years after treatmeant

  12. Assess the quality of life between the two groups with asses EHP-5 questionnaire

    average EHP-5 score ( Endometriosis Health Profil -5). Each item is rated on a four-point scale (never = 0, rarely = 1, sometimes = 2, often = 3, always = 4 and not relevant if not applicable). Scores on the EHP-5 core and modular questionnaire then are transformed on a scale of 0 (indicating best possible health status) to 100 (indicating worst possible health status)

    Measured: at inclusion,1 month, 6 months 1year 2 years and 3 years after treatmeant

  13. Assess the quality of life between the two groups with asses VAS questionnaire

    average VAS score ( Analog Visual Scale) : VAS measures pain intensity on a scale from 0 to 10 (or sometimes from 0 to 100)

    Measured: at inclusion,1 month, 6 months 1year 2 years and 3 years after treatmeant

  14. Evaluate signal and morphology changes on imaging MRI of parietal endometriosis nodules after cryoablation treatment

    average of size of endometriosis nodules after cryoablation treatment

    Measured: at inclusion,1 month, 6 months 1year 2 years and 3 years after treatmeant

  15. Evaluate signal and morphology changes on ultrasound imaging of parietal endometriosis nodules after cryoablation treatment

    average of size endometriosis nodules after cryoablation treatment

    Measured: at inclusion,1 month, 6 months 1year 2 years and 3 years after treatmeant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2024
  2. Study start15 Jun 2024
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06356831
Sponsor's protocol ID
Endomecryo
Acronym
Endomercyo
Status last verified
Nov 2025
First submitted
19 Mar 2024
Last updated
28 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Endometriosis and Cryotherapy Effect, run by Centre Hospitalier Intercommunal Creteil at 18 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 2 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Léo Razakamanantsoa, Dr (0157023567, Leo.Razakamanantsoa@chicreteil.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

creation of a national registry for the removal of nodules by cryoablation or surgery for parietal endometriosis (time frame: at inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06356831.

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 28 Nov 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in