EndometriosisENDO-HIFU-R2NCT05755958
Evaluation of the Efficacy of HIFU Treatment on Rectal Endometriosis Symptoms.
A study testing HIFU treatment in rectal Endometriosis in people with Endometriosis, run by EDAP TMS S.A. at 9 sites in France.
Trial summary
Rectal endometriosis (RE) induces lesions associated with painful symptoms that can alter quality of life. High Intensity Focused Ultrasound (HIFU) is a non-invasive ablative procedure using a high-intensity ultrasound probe to induce tissue devitalization using acoustic cavitation and thermal ablation. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- HIFU treatment in rectal Endometriosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 9 sitesFrance
- Study dates
- 3 Feb 2023to 31 Jul 2025
- Phase
- Interventional
- 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
Who may be able to join
- Patient 18 years of age or older,
- Rectal endometriosis on preoperative imaging with no other digestive location,
- Symptomatic patient (Acute pelvic pain > 3), in failure of drug treatment,
- Endometriotic lesion visible on ultrasound and confirmed on MRI,
- Centralized MRI, reviewed and validated by the MRI review committee,
- No current pregnancy and no pregnancy plan during the study period,
Show all 9Show fewer
- Patient agreeing not to change her hormonal treatment throughout the study period,
- Patient accepting the constraints of follow-up defined in the framework of the study,
- Patient affiliated to French health insurance.
Who cannot join
- Ongoing urogenital infection,
- Anorectal anatomy incompatible with HIFU treatment,
- Overall pain level considered intolerable by the patient and making a potential 3-months delay management impossible,
- History of segmental rectal resection or discoid resection,
- Patient with an implant located less than 1 cm from the treatment area,
- Inflammatory disease of the colon,
Show all 15Show fewer
- Allergy to latex,
- No scheduled endometriosis procedures during study follow-up,
- Treatment of endometriosis in the context of pregnancy desire for which a 3-month delay is not appropriate
- Patient with contraindications to MRI,
- Patient who has already received HIFU treatment for a rectal endometriotic lesion,
- Patient who does not speak or read French,
- Patient deprived of liberty following a judicial or administrative decision,
- Patient in labor or nursing,
- Patient under guardianship or curatorship
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Hopital Privé de Provence
Aix-en-Provence, 13080
CHU de Angers
Angers, 49000
Clinique Tivoli-Ducos
Bordeaux, 33000
Chu Estaing
Clermont-Ferrand, 63000
Hôpital du Kremlin Bicetre
Le Kremlin-Bicêtre, 94270
Hôpital privé Le Bois
Lille, 59000
Hopital de la Croix Rousse
Lyon, 69004
Hôpital COCHIN
Paris, 75014
CHU Strasbourg
Strasbourg, 67200
About this study
Official title: Doubled Blind Evaluation of the Efficacy of High Intensity Focused Ultrasound (HIFU) Treatment on Symptoms in Patients Treated for Rectal Endometriosis Compared to Sham.
Rectal endometriosis (RE) induces lesions associated with painful symptoms that can alter quality of life. High Intensity Focused Ultrasound (HIFU) is a non-invasive ablative procedure using a high-intensity ultrasound probe to induce tissue devitalization using acoustic cavitation and thermal ablation.
Focal One® is a transrectal HIFU device, which is validated to treat prostatic cancer.
In this comparative, randomized, double blind study , the primary objective is to evaluate the efficacy of the HIFU treatment of rectal endometriosis with Focal One® HIFU device on the Acute Pelvic Pain 3 months after HIFU treatment, in comparison to a Sham group.
- Conditions
- Endometriosis
- Being tested
- HIFU treatment in rectal Endometriosis, SHAM HIFU procedure
- Keywords
- Rectal Endometriosis, HIFU, FocalOne, High Intensity Focused Ultrasound
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIFU treatment in rectal EndometriosisDevice
HIFU treatment of rectal endometriosis
SHAM HIFU procedureDevice
SHAM HIFU procedure
| Study group | Role | What they receive |
|---|---|---|
| HIFU SHAM | Sham comparator | The patient placed in the right lateral decubitus position under general anesthesia or spinal anesthesia on the operating table. An endorectal probe is inserted in the patient's rectum. The probe includes an imaging transducer to visualize the endometriosis lesions and locate areas to be treated and an ultrasound therapy transducer to administer the HIFU treatment. After identification of the treatment area, HIFU shots will not be delivered on the lesion to be treated in a blinded manner.
Patients randomized to this arm will received exactly the same procedure as patients in the HIFU group with the exception of the HIFU shots. Receives: Device: SHAM HIFU procedure |
| HIFU TREATMENT | Active comparator | The patient placed in the right lateral decubitus position under general anesthesia or spinal anesthesia on the operating table. An endorectal probe is inserted in the patient's rectum. The probe includes an imaging transducer to visualize the endometriosis lesions and locate areas to be treated and an ultrasound therapy transducer to administer the HIFU treatment. After identification of the treatment area, HIFU shots will be delivered on the lesion to be treated in a blinded maner. Receives: Device: HIFU treatment in rectal Endometriosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the evolution in the level of acute pelvic pain compared to the sham intervention group.
The efficacy of HIFU treatment will be assessed by comparing the evolution in the level of acute pelvic pain assessed by Visual Analog Scale (VAS), ranging from 0 (best situation) to 10 (worst situation) at 3 months, to the pre-treatment pain level. The evolution in the HIFU group will be compared to those in the sham intervention group.
Measured: 3 months
Secondary outcomes (11)
Adverse Events occurrence and comparison between the two groups
Occurrence of adverse events during the 3 months of post-intervention follow-up will be evaluated in each group.
Measured: 3 months
Symptoms evolution evaluation
The Visual Analog Scale (VAS) symptoms questionnaire to assess gynecologic, digestive, urinary and general symptoms though 15 different visual scales ranging from 0 (representing no symptom) to 10 (representing the worst patient feeling).
Symptoms level will be collected before treatment and at 1 and 3 months after treatment. The symptoms' evolution in the HIFU group will be compared to those in the sham intervention group.
Measured: 1 and 3 months
Evaluation of anal continence
The Wexner total score ranges from 0 to 23 points corresponding to the sum of the 6 questions. Anal incontinence is considered as mild for a total score from 0 to 4, moderate when ranging from 5 to 9, important from 10 to 16, and considered as severe if equal to 16 or higher.
Symptoms level will be collected before treatment and at 1 and 3 months after treatment. The symptoms' evolution in the HIFU group will be compared to those in the sham intervention group.
Measured: 1 and 3 months
Evaluation of constipation
The KESS (Knowles-Eccersley-Scott Symptom) question is composed of the sum of 11 questions evaluating constipation. The total score ranges from 0 to 39 points corresponding to a total constipation status. Constipation is generally defined as a score above 10.
Symptoms level will be collected before treatment and at 1 and 3 months after treatment. The symptoms' evolution in the HIFU group will be compared to those in the sham intervention group.
Measured: 1 and 3 months
Evaluation of urinary symptoms
USP (Urinary Symptoms Profile) is a questionnaire that assesses urinary symptoms. It includes 13 questions grouped in 3 domains:
- Incontinence ranging from 0 to 9
- Overactive bladder ranging from 0 to 21
- Dysuria ranging from 0 to 9
The USP total score is the sum of all the 13 answers and ranges from 0 to 39 points, where 39 corresponds to the worst situation. Urinary dysfunction is generally defined as a score above 10.
Symptoms level will be collected before treatment and at 1 and 3 months after treatment. The symptoms' evolution in the HIFU group will be compared to those in the sham intervention group.
Measured: 1 and 3 months
Evaluation of sexual fonction
FSFI (Female Sexual Function Index scoring) is a validated questionnaire, including 19 items, which assesses different domains of sexual function (desire, arousal, lubrication, orgasm, satisfaction, and pain) in addition to providing an overall score regarding sexual function. FSFI total score ranges from 2 (worst situation) to 36 (best situation).
Symptoms level will be collected before treatment and at 1 and 3 months after treatment. The symptoms' evolution in the HIFU group will be compared to those in the sham intervention group.
Measured: 1 and 3 months
Quality of life evoluation
The questionnaire for the Quality of life evaluation is MOS-SF-36 (Medical Outcomes Study Short Form 36 item Health survey).
The MOS-SF-36 questionnaire consists of 36 questions which are divided into 8 different domains. Each domain is represented by the average of several questions (after recoding). Two scores, physical and mental, are then calculated. The maximum value of 100 corresponds to an optimal quality of life as described by the patient and zero the worst situation.
Quality of life will be collected before treatment and at 1 and 3 months after treatment. The quality of life evolution in the HIFU group will be compared to those in the sham intervention group.
Measured: 1 and 3 months
Volume lesion evaluation
The volume of endometriosis nodule will be evaluated on MRI, before treatment and at 3 months after treatment.
(blinded evaluation of the treatment groups). The volume variation observed in the HIFU group will be compared with those observed in the Sham Intervention group.
Measured: 3 months
Post treatment medication rate
The level of post-treatment medication during the first 10 days will be collected in the patient diary. The level of post-treatment medication in HIFU group will be compared to those in the sham intervention group.
Measured: 10 days
Post treatment pain rate
The level of pain will be evaluated by daily self-evaluation by the patients;rom 0 (best situation) to 10 (worst situation), and collected on the daily diary during the first 10 days post-intervention. The pain level in HIFU group will be compared to the sham intervention group.
Measured: 10 days
Overall recovery time evaluation
The overall recovery time will be evaluated by the patients on the patient diary.
The overall recovery time observed in the HIFU group will be compared to those observed in the Sham intervention group.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start3 Feb 2023
- Primary completion23 Jan 2024
- Study completion31 Jul 2025 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- EDAP TMS S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gil Dubernard, Pr, Principal investigator, EDAP TMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05755958
- Sponsor's protocol ID
- HIFU/F/21.12
- Acronym
- ENDO-HIFU-R2
- Status last verified
- Jun 2025
- First submitted
- 30 Jan 2023
- Last updated
- 5 Jun 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 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doubled Blind Evaluation of the Efficacy of High Intensity Focused Ultrasound (HIFU) Treatment on Symptoms in Patients Treated for Rectal Endometriosis Compared to Sham.
- ClinicalTrials.gov ID
- NCT05755958
- Acronym / sponsor ID
- ENDO-HIFU-R2 / HIFU/F/21.12
- Conditions
- Endometriosis
- Keywords
- Rectal Endometriosis, HIFU, FocalOne, High Intensity Focused Ultrasound
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- EDAP TMS S.A.Industry (pharma, biotech, devices)
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- 23 Jan 2024 (actual)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 6 Mar 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.
Rectal endometriosis (RE) induces lesions associated with painful symptoms that can alter quality of life. High Intensity Focused Ultrasound (HIFU) is a non-invasive ablative procedure using a high-intensity ultrasound probe to induce tissue devitalization using acoustic cavitation and thermal ablation.
Focal One® is a transrectal HIFU device, which is validated to treat prostatic cancer.
In this comparative, randomized, double blind study , the primary objective is to evaluate the efficacy of the HIFU treatment of rectal endometriosis with Focal One® HIFU device on the Acute Pelvic Pain 3 months after HIFU treatment, in comparison to a Sham group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIFU SHAM | Sham comparator | Device: SHAM HIFU procedureThe patient placed in the right lateral decubitus position under general anesthesia or spinal anesthesia on the operating table. An endorectal probe is inserted in the patient's rectum. The probe includes an imaging transducer to visualize the endometriosis lesions and locate areas to be treated and an ultrasound therapy transducer to administer the HIFU treatment. After identification of the treatment area, HIFU shots will not be delivered on the lesion to be treated in a blinded manner. Patients randomized to this arm will received exactly the same procedure as patients in the HIFU group with the exception of the HIFU shots. |
| HIFU TREATMENT | Active comparator | Device: HIFU treatment in rectal EndometriosisThe patient placed in the right lateral decubitus position under general anesthesia or spinal anesthesia on the operating table. An endorectal probe is inserted in the patient's rectum. The probe includes an imaging transducer to visualize the endometriosis lesions and locate areas to be treated and an ultrasound therapy transducer to administer the HIFU treatment. After identification of the treatment area, HIFU shots will be delivered on the lesion to be treated in a blinded maner. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient 18 years of age or older,
- Rectal endometriosis on preoperative imaging with no other digestive location,
- Symptomatic patient (Acute pelvic pain > 3), in failure of drug treatment,
- Endometriotic lesion visible on ultrasound and confirmed on MRI,
- Centralized MRI, reviewed and validated by the MRI review committee,
Key exclusion criteria (15 listed)
- Ongoing urogenital infection,
- Anorectal anatomy incompatible with HIFU treatment,
- Overall pain level considered intolerable by the patient and making a potential 3-months delay management impossible,
- History of segmental rectal resection or discoid resection,
- Patient with an implant located less than 1 cm from the treatment area,
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 |
|---|---|---|
| HIFU treatment in rectal EndometriosisHIFU treatment of rectal endometriosis | Device | HIFU TREATMENT |
| SHAM HIFU procedureSHAM HIFU procedure | Device | HIFU SHAM |
Primary outcome
Comparison of the evolution in the level of acute pelvic pain compared to the sham intervention group.
Time frame: 3 months
The efficacy of HIFU treatment will be assessed by comparing the evolution in the level of acute pelvic pain assessed by Visual Analog Scale (VAS), ranging from 0 (best situation) to 10 (worst situation) at 3 months, to the pre-treatment pain level. The evolution in the HIFU group will be compared to those in the sham intervention group.
11 secondary outcomes
Adverse Events occurrence and comparison between the two groups
Time frame: 3 months
Symptoms evolution evaluation
Time frame: 1 and 3 months
Evaluation of anal continence
Time frame: 1 and 3 months
Evaluation of constipation
Time frame: 1 and 3 months
Evaluation of urinary symptoms
Time frame: 1 and 3 months
Evaluation of sexual fonction
Time frame: 1 and 3 months
Quality of life evoluation
Time frame: 1 and 3 months
Volume lesion evaluation
Time frame: 3 months
Post treatment medication rate
Time frame: 10 days
Post treatment pain rate
Time frame: 10 days
Overall recovery time evaluation
Time frame: 3 months
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 5 Jun 2025.
Related trials for Endometriosis
Not yet recruiting
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
SIBO, Endometriosis
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Not yet recruitingObservational study
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
Endometriosis
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
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.
Gil Dubernard, Pr principal investigator
EDAP TMS
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIFU treatment in rectal Endometriosis in people with Endometriosis, run by EDAP TMS S.A. at 9 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 9 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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. Some participants in this study may receive a placebo. 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?
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?
Comparison of the evolution in the level of acute pelvic pain compared to the sham intervention group. (time frame: 3 months). 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 5 Jun 2025.