Endometriosis, RectumENDO-HIFU-R1NCT04494568
Evaluation of High Intensity Focused Ultrasound (HIFU) in the Treatment of Rectal Endometriosis
A study testing HIFU treatment in people with Endometriosis, Rectum, run by EDAP TMS S.A. at 5 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 25 years and older, women only
- Conditions the study is for
- Endometriosis, Rectum
- What is being tested?
- HIFU treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesFrance
- Study dates
- 27 Aug 2020to 30 Nov 2022
- 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 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged at least 25 years-old
- Rectal endometriosis in preoperative imaging, without other digestive locations (colon, ileum and small intentine)
- Symptomatic patient refusing hormonal treatment and/or surgery.
- Endometriosic nodule visible on echography with contrast and confirmed in Gadolinium MRI and difusion sequence (according to standardized protocol)
- Nodule with intrarectal protrusion of less than 50% (allowing the positioning of the probe in front of the rectal nodule)
- Distance from the upper pole to the anal margin ≤ 15 cm (measurement by MRI with intra-rectal contrast)
Show all 10Show fewer
- No curent pregnancy (negative BHCG <72h before the HIFU procedure) and no pregnancy project within 6 months after the HIFU procedure (post-treatment MRI delay)
- Patient agreeing not to change her hormone treatment for the duration of the study.
- Patient accepting the study constraints
- Health insurance affiliated patient or beneficiary of an equivalent coverage
Who cannot join
- Virgin patient
- Ongoing uro-genital infection
- Anorectal anatomy incompatible with HIFU therapy
- History of segmental rectal resection with mechanical anastomosis, shaving or discoid resection
- Patient with an implant within 1cm of the treatment area (stent, catheter, ESSURE® contraceptive implants).
- Inflammatory colon disease (ulcerative colitis, Crohn's disease and others)
Show all 13Show fewer
- Latex allergy
- Patient with contraindications to MRI
- Patient with contraindications to Gadolinium injection
- Patient previously treated with HIFU for a rectal endometriotic lesion
- Patient not speaking nor reading French
- Patient deprived of liberty following a legal or administrative decision
- Patient under guardianship or tutelage measure
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU de Angers
Angers
Clinique Tivoli-Ducos
Bordeaux
Hôpital BICETRE
Le Kremlin-Bicêtre
Clinique de Gynécologie
Lille
Hopital de la Croix Rousse
Lyon, 69004
About this study
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.
The primary objective of this clinical investigation is to evaluate the safety of the HIFU treatment of rectal endometriosis with Focal One® HIFU device.
- Conditions
- Endometriosis, Rectum
- Being tested
- HIFU treatment
- Keywords
- rectal endometriosis, HIFU
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIFU treatmentDevice
HIFU Treatment of rectal endometriosis
| Study group | Role | What they receive |
|---|---|---|
| HIFU intervention | Experimental | patients will benefit of an HIFU Treatment of their rectal endometriosis Receives: Device: HIFU treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the tolerance of rectal endometriosis treatment with HIFU
The tolerance of the treatment will be evaluated by the analysis of adverse events occurrence at 6 months post-HIFU treatment
Measured: 6 months
Secondary outcomes (8)
Evaluation of the gynecological symptoms evolution of patients after HIFU treatment
EVA symptom Questionnaires
Measured: at 1 month, 3 months and 6 months post-intervention
Evaluation of the of quality of life evolution of patients after HIFU treatment
Quality of life questionnaire : MOS- SF-36
Measured: at 1 month, 3 months and 6 months post-intervention,
Evaluation of the evolution of the nodule's volume
The pre- and post-treatment comparison of the volume of the endometriodsis nodule measurement.
Measured: at 6 months
Evaluation of the post-intervention analgesic treatment
The level of medication during the fisrt 10 days post treatment will be studied by analysing the data collected in patient book.
Measured: during the fisrt 10 days post treatment.
Evaluation of the digestive symptoms evolution of patients after HIFU treatment
Wexner
Measured: at 1 month, 3 months and 6 months post-intervention
Evaluation of the digestive symptoms evolution of patients after HIFU treatment
Kess questionnaires
Measured: at 1 month, 3 months and 6 months post-intervention
Evaluation of the sexual symptoms evolution of patients after HIFU treatment
SFSI questionnaire
Measured: at 1 month, 3 months and 6 months post-intervention
Evaluation of the urinary symptoms evolution of patients after HIFU treatment
USP questionnaire
Measured: at 1 month, 3 months and 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start27 Aug 2020
- Primary completion1 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometriosis, RectumStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- INTERVENTIONAL, PROSPECTIVE, MULTICENTRIC, NON-RANDOMIZED AND NON-CONROLLED STUDY
- Masking
- None (open label)
- 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, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04494568
- Sponsor's protocol ID
- HIFU-F-20.01
- Acronym
- ENDO-HIFU-R1
- Status last verified
- Jan 2023
- First submitted
- 22 Jul 2020
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dubernard G, Maissiat E, Legendre G, Dennis T, Capmas P, Warembourg S, Descamps P, Chavrier F, Roman H, Fernandez H, Nguyen-Ba E, Merlot B, Rousset P, Lafon C, Philip CA. Evaluating the safety of high-intensity focused ultrasound treatment for rectal endometriosis: results from a French prospective multicentre study including 60 patients. Hum Reprod. 2024 Aug 1;39(8):1673-1683. doi: 10.1093/humrep/deae127.
PubMed 38914481
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of High Intensity Focused Ultrasound (HIFU) in the Treatment of Rectal Endometriosis
- ClinicalTrials.gov ID
- NCT04494568
- Acronym / sponsor ID
- ENDO-HIFU-R1 / HIFU-F-20.01
- Conditions
- Endometriosis, Rectum
- Keywords
- rectal endometriosis, HIFU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- EDAP TMS S.A.Industry (pharma, biotech, devices)
- Study start
- 27 Aug 2020 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 31 Jul 2020 (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.
The primary objective of this clinical investigation is to evaluate the safety of the HIFU treatment of rectal endometriosis with Focal One® HIFU device.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- INTERVENTIONAL, PROSPECTIVE, MULTICENTRIC, NON-RANDOMIZED AND NON-CONROLLED STUDY
| Arm | Type | Receives |
|---|---|---|
| HIFU intervention | Experimental | Device: HIFU treatmentpatients will benefit of an HIFU Treatment of their rectal endometriosis |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients aged at least 25 years-old
- Rectal endometriosis in preoperative imaging, without other digestive locations (colon, ileum and small intentine)
- Symptomatic patient refusing hormonal treatment and/or surgery.
- Endometriosic nodule visible on echography with contrast and confirmed in Gadolinium MRI and difusion sequence (according to standardized protocol)
- Nodule with intrarectal protrusion of less than 50% (allowing the positioning of the probe in front of the rectal nodule)
Key exclusion criteria (13 listed)
- Virgin patient
- Ongoing uro-genital infection
- Anorectal anatomy incompatible with HIFU therapy
- History of segmental rectal resection with mechanical anastomosis, shaving or discoid resection
- Patient with an implant within 1cm of the treatment area (stent, catheter, ESSURE® contraceptive implants).
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 treatmentHIFU Treatment of rectal endometriosis | Device | HIFU intervention |
Primary outcome
Evaluate the tolerance of rectal endometriosis treatment with HIFU
Time frame: 6 months
The tolerance of the treatment will be evaluated by the analysis of adverse events occurrence at 6 months post-HIFU treatment
8 secondary outcomes
Evaluation of the gynecological symptoms evolution of patients after HIFU treatment
Time frame: at 1 month, 3 months and 6 months post-intervention
Evaluation of the of quality of life evolution of patients after HIFU treatment
Time frame: at 1 month, 3 months and 6 months post-intervention,
Evaluation of the evolution of the nodule's volume
Time frame: at 6 months
Evaluation of the post-intervention analgesic treatment
Time frame: during the fisrt 10 days post treatment.
Evaluation of the digestive symptoms evolution of patients after HIFU treatment
Time frame: at 1 month, 3 months and 6 months post-intervention
Evaluation of the digestive symptoms evolution of patients after HIFU treatment
Time frame: at 1 month, 3 months and 6 months post-intervention
Evaluation of the sexual symptoms evolution of patients after HIFU treatment
Time frame: at 1 month, 3 months and 6 months post-intervention
Evaluation of the urinary symptoms evolution of patients after HIFU treatment
Time frame: at 1 month, 3 months and 6 months post-intervention
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 1 Feb 2023.
- Derived from this study: PubMed 38914481Dubernard G, Maissiat E, Legendre G, Dennis T, Capmas P, Warembourg S, Descamps P, Chavrier F, Roman H, Fernandez H, Nguyen-Ba E, Merlot B, Rousset P, Lafon C, Philip CA. Evaluating the safety of high-intensity focused ultrasound treatment for rectal endometriosis: results from a French prospective multicentre study including 60 patients. Hum Reprod. 2024 Aug 1;39(8):1673-1683. doi: 10.1093/humrep/deae127.
Related trials for Endometriosis, Rectum
Not yet recruitingObservational study
Clinical Impact of Ultrasound Diagnosis in Bowel Endometriosis
Endometriosis, Endometriosis Rectum
Not yet recruitingObservational study
Intraoperative Sono-assessment In Deep Endometriosis
Endometriosis, Endometriosis-related Pain
Not yet recruitingObservational study
Intraoperative vs Transvaginal Ultrasound in Rectosigmoid Endometriosis
Endometriosis, Endometriosis of Colon
Not yet recruitingObservational study
The Association Between Deep Endometriosis and the Occurrence of Colorectal Carcinoma
Endometriosis, Deep Endometriosis
RecruitingObservational study
The (Cost-)Effectiveness of Surgical Excision of Colorectal Endometriosis Compared to ART Treatment Trajectory
Endometriosis, Rectum, Endometriosis of Colon
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
Hospices Civils de Lyon
5 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 people with Endometriosis, Rectum, run by EDAP TMS S.A. at 5 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 10 inclusion and 13 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 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Evaluate the tolerance of rectal endometriosis treatment with HIFU (time frame: 6 months). 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 NCT04494568, which also lists 1 linked publication.
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 1 Feb 2023.