EndometriosisNCT03613298
Treatment by HIFU With Focal One® of Posterior Deep Infiltrating Endometriosis Lesions With Intestinal Involvement.
A study testing HIFU (Focal One®) in people with Endometriosis, run by EDAP TMS S.A. at 1 site in France.
Trial summary
Deep invasive endometriosis (DIE) includes lesions of the rectosigmoid. Theses lesions are 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… Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- HIFU (Focal One®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 21 Sep 2015to May 2019
- 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
- Age > 25 years
- Isolated recto-sigmoid DIE lesion, with no other endometriosis location on imaging examination (intestinal, urinary or ovarian), the persistence of symptoms despite hormonal treatment and therefore consideration for surgical management.
- Localization of endometriosic lesion described by US, confirmed by MRI
- Negative urinary pregnancy test and No intention to get pregnant during the following 6 months
- Affiliated to the French Social Security System
Who cannot join
- Hormonal treatment of endometriosis by Luteinizing Hormone Releasing Hormone agonist (LHRH analogs) of less than 3 months
- Breastfeeding female
- Uro-genital infection in progress (the infection has to be treated before HIFU treatment)
- Anatomical abnormality of the rectum
- Anterior surgery at the level of the anus or rectum
- Presence of an implant (stent, catheter, contraceptive implant) located less than 1 cm from the treatment area.
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- History of intestinal inflammatory pathology
- Allergy to latex
- Female with a medical contraindication on MRI
- Female with a medical contraindication to Sonovue® injection
- Female not able to understand the objectives of the study
- Legal person protected by law
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Location and the Treatment by High-intensity Focused Ultrasounds (HIFU) of Posterior Deep Infiltrating Endometriosis (DIE) Lesions With Intestinal Involvement
Deep invasive endometriosis (DIE) includes lesions of the rectosigmoid. Theses lesions are 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 trial is to evaluate the ability of the Focal One® HIFU device to detect and target posterior DIE lesions with intestinal involvement. The secondary objectives are to perform a HIFU lesion, to evaluate morphological modifications of the nodule in post-therapeutic imaging scans, to assess evolution of gynecological symptoms, intestinal symptoms, and patients' quality of life after treatment by HIFU and to collect safety data.
Read the detailed description
20 Subjects with deep invasive endometriosis (DIE) will receive the HIFU treatment with Focal One® device.
Subjects harboring an isolated recto-sigmoid DIE lesion with a persistence of symptoms despite hormonal treatment will be installed on the Focal One® device to:
- Evaluate its ability to locate and assess the volume of the endometriosic lesion
- Treat the targeted lesion by HIFU energy application. Real-time guided ultrasonography will be used to determine the location of the endometriosic nodule. Succession of HIFU exposure will be then used to treat maximum lesion volume, excluding a security margin of 3 mm with the digestive mucosae to prevent risk of fistulae.
Patients will fill-out questionnaires on gynecological and intestinal symptoms and on quality of life before treatment and at 1 and 6 months after HIFU procedure. Imaging follow-up scans will be organized at 1 and 6 months and by a pelvic MRI scan at 3/6 months.
- Conditions
- Endometriosis
- Being tested
- HIFU (Focal One®)
- Keywords
- HIFU, High Intensity Focused Ultrasound, DIE, rectal endometriosis, safety profile, Deep invasive endometriosis, Endometriosis, rectum
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIFU (Focal One®)Device
Also called High-Intensity Focused Ultrasounds
Endometriosic lesion localization and HIFU treatment will be conducted with the Focal One® device. The treatment area will be defined using sonography, pelvic MRI and a transrectal sonography data. Once the pre-defined lesion will be located with Focal One device, succession of HIFU exposure will then be used to treat maximum lesion volume, excluding a security margin of 3 mm with the digestive mucosae.
| Study group | Role | What they receive |
|---|---|---|
| HIFU (Focal One®) Treatment | Experimental | Subjects harboring an isolated recto-sigmoid deep invasive endometriosis (DIE) lesion with a persistence of symptoms despite hormonal treatment will be installed on the Focal One® device to:
* Evaluate its ability to locate and assess the volume of the endometriosic lesion
* Treat the targeted lesion by HIFU energy application. Real-time guided ultrasonography will be used to determine the location of the endometriosic nodule.
Patients will fill-out questionnaires on gynecological and intestinal symptoms and on quality of life before treatment and 1 and 6 months after HIFU. Imaging follow-up scans will be organized at 1 and 6 months and by a pelvic MRI scan at 3/6 months. Receives: Device: HIFU (Focal One®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Targeting of the endometriosic lesion
The main criterion of evaluation will lie on the targeting of the Endometriosic lesion with the Focal One® probe.
Measure of the volume of the Endometriosic lesion to treat: targeted volume (estimation from the measures of the length, the height and the width of the nodule).
Measured: Day 1
Secondary outcomes (10)
Anatomical position of the Focal One probe
The objective is to evaluate the position of the probe within the rectum before HIFU treatment.
Measured: Day 1
Effect of HIFU treatment on endometriosic lesion
Ratio calculation between targeted volume and treated volume and Evaluation of HIFU on symptomatology
Measured: Day 1
Safety of the procedure: assessment of complications during the procedure attributable to the technique
Complications during HIFU treatment attributable to the HIFU energy deposit or the Focal One are described here.
Measured: Day 1
Assessment of Adverse Events during the 6 months follow-up attributable to the technique
Complications post HIFU treatment.
Measured: 6 months
Medical Outcome assessment (Study Short Form-36)
self-administrated questionnaire: French version of the 36-item Short Form Survey (SF-36)
Measured: 6 months
endometriosis health profile assessment
self-administrated questionnaire: endometriosis health profile (EHP-5)
Measured: 6 months
Urinary symptom profile assessment
self-administrated questionnaire: urinary symptom profile (USP)
Measured: 6 months
Sexual function assessment
self-administrated questionnaire: Female Sexual Function Index (FSFI)
Measured: 6 months
Constipation assessment
self-administrated questionnaire: Knowles-Eccersley-Scott-Symptom Questionnaire (KESS score)
Measured: 6 months
Anal continence assessment
self-administrated questionnaire: Wexner score of anal continence
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start21 Sep 2015
- Primary completionMay 2019
- Study completionMay 2019
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- EDAP TMS S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gil DUBERNARD, MD PhD, Principal investigator, Hôpital de la Croix Rousse Service de Gynécologie-Obstétrique, Hospices Civils de Lyon, 103, Grande rue de la Croix Rousse 69 004 Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613298
- Sponsor's protocol ID
- HIFU/F/13.12
- Status last verified
- Jul 2019
- First submitted
- 20 Jul 2018
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Location and the Treatment by High-intensity Focused Ultrasounds (HIFU) of Posterior Deep Infiltrating Endometriosis (DIE) Lesions With Intestinal Involvement
- ClinicalTrials.gov ID
- NCT03613298
- Acronym / sponsor ID
- HIFU/F/13.12
- Conditions
- Endometriosis
- Keywords
- HIFU, High Intensity Focused Ultrasound, DIE, rectal endometriosis, safety profile, Deep invasive endometriosis, Endometriosis, rectum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- EDAP TMS S.A.Industry (pharma, biotech, devices)
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 21 Sep 2015 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 3 Aug 2018 (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.
Deep invasive endometriosis (DIE) includes lesions of the rectosigmoid. Theses lesions are 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 trial is to evaluate the ability of the Focal One® HIFU device to detect and target posterior DIE lesions with intestinal involvement. The secondary objectives are to perform a HIFU lesion, to evaluate morphological modifications of the nodule in post-therapeutic imaging scans, to assess evolution of gynecological symptoms, intestinal symptoms, and patients' quality of life after treatment by HIFU and to collect safety data.
Detailed description
20 Subjects with deep invasive endometriosis (DIE) will receive the HIFU treatment with Focal One® device.
Subjects harboring an isolated recto-sigmoid DIE lesion with a persistence of symptoms despite hormonal treatment will be installed on the Focal One® device to:
- Evaluate its ability to locate and assess the volume of the endometriosic lesion
- Treat the targeted lesion by HIFU energy application. Real-time guided ultrasonography will be used to determine the location of the endometriosic nodule. Succession of HIFU exposure will be then used to treat maximum lesion volume, excluding a security margin of 3 mm with the digestive mucosae to prevent risk of fistulae.
Patients will fill-out questionnaires on gynecological and intestinal symptoms and on quality of life before treatment and at 1 and 6 months after HIFU procedure. Imaging follow-up scans will be organized at 1 and 6 months and by a pelvic MRI scan at 3/6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIFU (Focal One®) Treatment | Experimental | Device: HIFU (Focal One®)Subjects harboring an isolated recto-sigmoid deep invasive endometriosis (DIE) lesion with a persistence of symptoms despite hormonal treatment will be installed on the Focal One® device to: * Evaluate its ability to locate and assess the volume of the endometriosic lesion * Treat the targeted lesion by HIFU energy application. Real-time guided ultrasonography will be used to determine the location of the endometriosic nodule. Patients will fill-out questionnaires on gynecological and intestinal symptoms and on quality of life before treatment and 1 and 6 months after HIFU. Imaging follow-up scans will be organized at 1 and 6 months and by a pelvic MRI scan at 3/6 months. |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 25 years
- Isolated recto-sigmoid DIE lesion, with no other endometriosis location on imaging examination (intestinal, urinary or ovarian), the persistence of symptoms despite hormonal treatment and therefore consideration for surgical management.
- Localization of endometriosic lesion described by US, confirmed by MRI
- Negative urinary pregnancy test and No intention to get pregnant during the following 6 months
- Affiliated to the French Social Security System
Key exclusion criteria (12 listed)
- Hormonal treatment of endometriosis by Luteinizing Hormone Releasing Hormone agonist (LHRH analogs) of less than 3 months
- Breastfeeding female
- Uro-genital infection in progress (the infection has to be treated before HIFU treatment)
- Anatomical abnormality of the rectum
- Anterior surgery at the level of the anus or rectum
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 (Focal One®)Also: High-Intensity Focused UltrasoundsEndometriosic lesion localization and HIFU treatment will be conducted with the Focal One® device. The treatment area will be defined using sonography, pelvic MRI and a transrectal sonography data. Once the pre-defined lesion will be located with Focal One device, succession of HIFU exposure will then be used to treat maximum lesion volume, excluding a security margin of 3 mm with the digestive mucosae. | Device | HIFU (Focal One®) Treatment |
Primary outcome
Targeting of the endometriosic lesion
Time frame: Day 1
The main criterion of evaluation will lie on the targeting of the Endometriosic lesion with the Focal One® probe. Measure of the volume of the Endometriosic lesion to treat: targeted volume (estimation from the measures of the length, the height and the width of the nodule).
10 secondary outcomes
Anatomical position of the Focal One probe
Time frame: Day 1
Effect of HIFU treatment on endometriosic lesion
Time frame: Day 1
Safety of the procedure: assessment of complications during the procedure attributable to the technique
Time frame: Day 1
Assessment of Adverse Events during the 6 months follow-up attributable to the technique
Time frame: 6 months
Medical Outcome assessment (Study Short Form-36)
Time frame: 6 months
endometriosis health profile assessment
Time frame: 6 months
Urinary symptom profile assessment
Time frame: 6 months
Sexual function assessment
Time frame: 6 months
Constipation assessment
Time frame: 6 months
Anal continence assessment
Time frame: 6 months
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 31 Jul 2019.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Gil DUBERNARD, MD PhD principal investigator
Hôpital de la Croix Rousse Service de Gynécologie-Obstétrique, Hospices Civils de Lyon, 103, Grande rue de la Croix Rousse 69 004 Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIFU (Focal One®) in people with 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 5 inclusion and 12 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 31 Jul 2019. 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?
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?
Targeting of the endometriosic lesion (time frame: Day 1). 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 31 Jul 2019.