EndometriosisENDO HIFU FUNCT07179419
Evaluation of the Long-term Therapeutic Effect of High-Intensity Focused Ultrasound (HIFU) Treatment in Patients With Rectal Endometriosis
An observational study of Endometriosis, run by EDAP TMS S.A. at 1 site in France.
Trial summary
Evaluate the long-term effects of HIFU treatment for rectal endometriosis. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 10 Oct 2021to 30 Sep 2029
- 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: All patients who received HIFU treatment for rectal endometriosis as part of studies HIFU/F/13.12, HIFU/F/20.01, and HIFU/F/21.12.
Who may be able to join
- Patients who have been treated with HIFU for rectal endometriosis included in study HIFU/F/13.12, study HIFU/F/20.01 (ENDO HIFU R1) or study HIFU/F/21.12 (ENDO HIFU R2)
- Agreeing to participate in the study
- Patients with internet access so that they can complete the questionnaires electronically.
Who cannot join
- Patients deprived of their liberty following a judicial or administrative decision,
- Patients under guardianship or conservatorship.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hopital de la Croix Rousse
Lyon, 69004
Gil Pr Dubernard, +334 72 11 80 88, gil.dubernard@chu-lyon.fr
About this study
Evaluate the long-term effects of HIFU treatment for rectal endometriosis.
Read the detailed description
This study evaluates the long-term effects of HIFU treatment on endometriosis symptoms in patients who have received this treatment. The patients included will have participated in the following studies: HIFU/F/13.12, ENDO HIFU R1, and ENDO HIFU R2.
Patients will complete an electronic questionnaire and receive a telephone call to monitor these parameters.
- Conditions
- Endometriosis
- Keywords
- HIFU, FocalOne, Rectal Endometriosis
- Medical subject headings
- Endometriosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the SF36 score assessed before HIFU treatment with that assessed in the long term after HIFU treatment.
Measured: every year during 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start10 Oct 2021
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EDAP TMS S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07179419
- Sponsor's protocol ID
- HIFU/F/21.04
- Acronym
- ENDO HIFU FU
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 17 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 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Long-term Therapeutic Effect of High-Intensity Focused Ultrasound (HIFU) Treatment in Patients With Rectal Endometriosis
- ClinicalTrials.gov ID
- NCT07179419
- Acronym / sponsor ID
- ENDO HIFU FU / HIFU/F/21.04
- Conditions
- Endometriosis
- Keywords
- HIFU, FocalOne, Rectal Endometriosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- EDAP TMS S.A.Industry (pharma, biotech, devices)
- Study start
- 10 Oct 2021 (actual)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 17 Sep 2025 (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.
Evaluate the long-term effects of HIFU treatment for rectal endometriosis.
Detailed description
This study evaluates the long-term effects of HIFU treatment on endometriosis symptoms in patients who have received this treatment. The patients included will have participated in the following studies: HIFU/F/13.12, ENDO HIFU R1, and ENDO HIFU R2.
Patients will complete an electronic questionnaire and receive a telephone call to monitor these parameters.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who received HIFU treatment for rectal endometriosis as part of studies HIFU/F/13.12, HIFU/F/20.01, and HIFU/F/21.12.
Key inclusion criteria (3 listed)
- Patients who have been treated with HIFU for rectal endometriosis included in study HIFU/F/13.12, study HIFU/F/20.01 (ENDO HIFU R1) or study HIFU/F/21.12 (ENDO HIFU R2)
- Agreeing to participate in the study
- Patients with internet access so that they can complete the questionnaires electronically.
Key exclusion criteria (2 listed)
- Patients deprived of their liberty following a judicial or administrative decision,
- Patients under guardianship or conservatorship.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Compare the SF36 score assessed before HIFU treatment with that assessed in the long term after HIFU treatment.
Time frame: every year during 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by EDAP TMS S.A. at 1 site 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 3 inclusion and 2 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 17 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 1 site 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 Djamila BENNAT (+33 472 153 125, affaires-cliniques@edap-tms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the SF36 score assessed before HIFU treatment with that assessed in the long term after HIFU treatment. (time frame: every year during 5 years). 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 17 Sep 2025.