Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT05227456
Status:
WITHDRAWN
Last Update Posted:
2025-11-25
First Post:
2022-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Failed Endometrial Ablation Treatment With Implantable Progesterone (FEAT) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008796', 'term': 'Metrorrhagia'}, {'id': 'D004412', 'term': 'Dysmenorrhea'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'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'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D017699', 'term': 'Pelvic Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C044815', 'term': 'etonogestrel'}, {'id': 'D004343', 'term': 'Drug Implants'}, {'id': 'D016254', 'term': 'Mutagenesis, Insertional'}], 'ancestors': [{'id': 'D003692', 'term': 'Delayed-Action Preparations'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D015202', 'term': 'Protein Engineering'}, {'id': 'D005818', 'term': 'Genetic Engineering'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D009154', 'term': 'Mutation'}, {'id': 'D014644', 'term': 'Genetic Variation'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}, {'id': 'D016296', 'term': 'Mutagenesis'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Difficulty in Recruitment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2022-01-26', 'studyFirstSubmitQcDate': '2022-01-26', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hysterectomy', 'timeFrame': 'Occurrence of hysterectomy will be documented any time during the 3 year follow up period', 'description': 'occurrence of hysterectomy'}], 'secondaryOutcomes': [{'measure': 'Vaginal bleeding', 'timeFrame': 'PBAC score will be documented at baseline and 3, 6, 12, 18, 24, 30, and 36 months', 'description': 'Pictorial Blood Loss Assessment Chart (PBAC) score, minimum score = 0mL, maximum score = n/a, higher score indicates higher menstrual blood loss'}, {'measure': 'Pelvic Pain', 'timeFrame': 'VAS will be documented at baseline and 3, 6, 12, 18, 24, 30, and 36 months', 'description': 'Assessment of pelvic pain using Visual Analogue Scale (VAS), minimum score = 0, maximum score = 10, higher score indicates more pain'}, {'measure': 'Time to Hysterectomy', 'timeFrame': 'Time of hysterectomy will be documented any time during the 3 year follow up period', 'description': 'Time from booking of hysterectomy to actual hysterectomy will be documented'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['abnormal uterine bleeding', 'pain', 'dysmenorrhea', 'endometrial ablation'], 'conditions': ['Abnormal Uterine Bleeding', 'Dysmenorrhea']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess the efficacy of an implantable etonogestrel device in reducing hysterectomy rate in patients with a failed endometrial ablation.', 'detailedDescription': 'The researchers aim to determine whether use of etonogestrel implant in patients with failed endometrial ablation significantly decreases hysterectomy rate. Changes in pelvic pain and vaginal bleeding will be assessed. Time to hysterectomy will be examined.\n\nThe researchers hypothesize that treatment of failed endometrial ablation with etonogestrel implant will decrease pelvic pain and vaginal bleeding resulting in a significantly decreased need for hysterectomy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Previous endometrial ablation\n* Pelvic pain and/or vaginal bleeding seeking treatment\n\nExclusion Criteria:\n\n* Previous or current VTE\n* Liver tumour, benign or malignant, or active liver disease\n* Undiagnosed abnormal genital bleeding\n* Known or suspected breast cancer\n* Uncontrolled hypertension\n* Allergy to component of etonogestrel implant\n* Lack of patient consent'}, 'identificationModule': {'nctId': 'NCT05227456', 'acronym': 'FEATS', 'briefTitle': 'Failed Endometrial Ablation Treatment With Implantable Progesterone (FEAT) Study', 'organization': {'class': 'OTHER', 'fullName': 'Saskatchewan Health Authority - Regina Area'}, 'officialTitle': 'Failed Endometrial Ablation Treatment With Implantable Progesterone (FEAT) Study', 'orgStudyIdInfo': {'id': 'REB-22-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Etonogestrel implant', 'description': 'The participants will receive an etonogestrel 68mg implant', 'interventionNames': ['Drug: Etonogestrel 68mg implant', 'Device: Etonogestrel 68mg implant']}], 'interventions': [{'name': 'Etonogestrel 68mg implant', 'type': 'DRUG', 'otherNames': ['Nexplanon'], 'description': 'Implant will be inserted', 'armGroupLabels': ['Etonogestrel implant']}, {'name': 'Etonogestrel 68mg implant', 'type': 'DEVICE', 'otherNames': ['Nexplanon'], 'description': 'Implant will be inserted', 'armGroupLabels': ['Etonogestrel implant']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Regina', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Saskatchewan Health Authority', 'geoPoint': {'lat': 50.45008, 'lon': -104.6178}}], 'overallOfficials': [{'name': 'Sarah N Smith, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Obstetrician Gynecologist'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saskatchewan Health Authority - Regina Area', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Saskatchewan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Obstetrician Gynecologist, Principal Investigator, Assistant Professor', 'investigatorFullName': 'Sarah Smith', 'investigatorAffiliation': 'Saskatchewan Health Authority - Regina Area'}}}}