Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2025-12-24 @ 5:36 PM
Study NCT ID:
NCT04494568
Status:
COMPLETED
Last Update Posted:
2023-02-01
First Post:
2020-07-22
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of High Intensity Focused Ultrasound (HIFU) in the Treatment of Rectal Endometriosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'INTERVENTIONAL, PROSPECTIVE, MULTICENTRIC, NON-RANDOMIZED AND NON-CONROLLED STUDY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-31', 'studyFirstSubmitDate': '2020-07-22', 'studyFirstSubmitQcDate': '2020-07-28', 'lastUpdatePostDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the tolerance of rectal endometriosis treatment with HIFU', 'timeFrame': '6 months', 'description': 'The tolerance of the treatment will be evaluated by the analysis of adverse events occurrence at 6 months post-HIFU treatment'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the gynecological symptoms evolution of patients after HIFU treatment', 'timeFrame': 'at 1 month, 3 months and 6 months post-intervention', 'description': 'EVA symptom Questionnaires'}, {'measure': 'Evaluation of the of quality of life evolution of patients after HIFU treatment', 'timeFrame': 'at 1 month, 3 months and 6 months post-intervention,', 'description': 'Quality of life questionnaire : MOS- SF-36'}, {'measure': "Evaluation of the evolution of the nodule's volume", 'timeFrame': 'at 6 months', 'description': 'The pre- and post-treatment comparison of the volume of the endometriodsis nodule measurement.'}, {'measure': 'Evaluation of the post-intervention analgesic treatment', 'timeFrame': 'during the fisrt 10 days post treatment.', 'description': 'The level of medication during the fisrt 10 days post treatment will be studied by analysing the data collected in patient book.'}, {'measure': 'Evaluation of the digestive symptoms evolution of patients after HIFU treatment', 'timeFrame': 'at 1 month, 3 months and 6 months post-intervention', 'description': 'Wexner'}, {'measure': 'Evaluation of the digestive symptoms evolution of patients after HIFU treatment', 'timeFrame': 'at 1 month, 3 months and 6 months post-intervention', 'description': 'Kess questionnaires'}, {'measure': 'Evaluation of the sexual symptoms evolution of patients after HIFU treatment', 'timeFrame': 'at 1 month, 3 months and 6 months post-intervention', 'description': 'SFSI questionnaire'}, {'measure': 'Evaluation of the urinary symptoms evolution of patients after HIFU treatment', 'timeFrame': 'at 1 month, 3 months and 6 months post-intervention', 'description': 'USP questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rectal endometriosis, HIFU'], 'conditions': ['Endometriosis, Rectum']}, 'referencesModule': {'references': [{'pmid': '38914481', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe primary objective of this clinical investigation is to evaluate the safety of the HIFU treatment of rectal endometriosis with Focal One® HIFU device.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients aged at least 25 years-old\n* Rectal endometriosis in preoperative imaging, without other digestive locations (colon, ileum and small intentine)\n* Symptomatic patient refusing hormonal treatment and/or surgery.\n* Endometriosic nodule visible on echography with contrast and confirmed in Gadolinium MRI and difusion sequence (according to standardized protocol)\n* Nodule with intrarectal protrusion of less than 50% (allowing the positioning of the probe in front of the rectal nodule)\n* Distance from the upper pole to the anal margin ≤ 15 cm (measurement by MRI with intra-rectal contrast)\n* 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)\n* Patient agreeing not to change her hormone treatment for the duration of the study.\n* Patient accepting the study constraints\n* Health insurance affiliated patient or beneficiary of an equivalent coverage\n\nExclusion Criteria:\n\n* Virgin patient\n* Ongoing uro-genital infection\n* Anorectal anatomy incompatible with HIFU therapy\n* History of segmental rectal resection with mechanical anastomosis, shaving or discoid resection\n* Patient with an implant within 1cm of the treatment area (stent, catheter, ESSURE® contraceptive implants).\n* Inflammatory colon disease (ulcerative colitis, Crohn's disease and others)\n* Latex allergy\n* Patient with contraindications to MRI\n* Patient with contraindications to Gadolinium injection\n* Patient previously treated with HIFU for a rectal endometriotic lesion\n* Patient not speaking nor reading French\n* Patient deprived of liberty following a legal or administrative decision\n* Patient under guardianship or tutelage measure"}, 'identificationModule': {'nctId': 'NCT04494568', 'acronym': 'ENDO-HIFU-R1', 'briefTitle': 'Evaluation of High Intensity Focused Ultrasound (HIFU) in the Treatment of Rectal Endometriosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'EDAP TMS S.A.'}, 'officialTitle': 'Evaluation of High Intensity Focused Ultrasound (HIFU) in the Treatment of Rectal Endometriosis', 'orgStudyIdInfo': {'id': 'HIFU-F-20.01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HIFU intervention', 'description': 'patients will benefit of an HIFU Treatment of their rectal endometriosis', 'interventionNames': ['Device: HIFU treatment']}], 'interventions': [{'name': 'HIFU treatment', 'type': 'DEVICE', 'description': 'HIFU Treatment of rectal endometriosis', 'armGroupLabels': ['HIFU intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Angers', 'country': 'France', 'facility': 'CHU de Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Bordeaux', 'country': 'France', 'facility': 'Clinique Tivoli-Ducos', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': 'Hôpital BICETRE', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'city': 'Lille', 'country': 'France', 'facility': 'Clinique de Gynécologie', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69004', 'city': 'Lyon', 'country': 'France', 'facility': 'Hopital de la Croix Rousse', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Gil DUBERNARD, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EDAP TMS S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}