Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:56 PM
Study NCT ID:
NCT04779658
Status:
UNKNOWN
Last Update Posted:
2021-03-03
First Post:
2021-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Laparoscopic Essure Device Removal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-02', 'studyFirstSubmitDate': '2021-02-18', 'studyFirstSubmitQcDate': '2021-03-02', 'lastUpdatePostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of quality of life after ESSURE removal', 'timeFrame': 'Preoperative', 'description': 'Evaluation of quality of life after ESSURE removal by SF 36 questionnaire Preoperative questionnaires will be collected from medical record. Patients will be contacted by phone call to answer to this questionnaire for the long term follow-up'}, {'measure': 'Evaluation of quality of life after ESSURE removal', 'timeFrame': 'three-months post-operative', 'description': 'Evaluation of quality of life after ESSURE removal by SF 36 questionnaire three-months post-operative questionnaires will be collected from medical record. Patients will be contacted by phone call to answer to this questionnaire for the long term follow-up'}], 'secondaryOutcomes': [{'measure': 'Evaluation of morbidity of ESSURE removal', 'timeFrame': '1 day', 'description': "description of per et postoperative complications (patient's medical record and by phone call)"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Essure device removal', 'Quality of life'], 'conditions': ['Contraception']}, 'descriptionModule': {'briefSummary': 'In recent years, several symptoms have been attributed to Essure, including pelvic pain and other general symptoms. Consequently, an increasing number of patients request Essure removal for alleged adverse reactions to the device.\n\nStudy Objective: To evaluate the quality of life of patients who underwent Essure\\_ device removal and morbidity of this surgery.\n\nDesign: Prospective observational cohort study. Setting: Academic hospitals of La Conception, Marseille, and Arnaud-de-Villeneuve, Montpellier, France.\n\nPatients: Women who underwent Essure\\_ device removal by salpingectomy, between February 2017 and August 2018.\n\nMethods : The following information have been collected during preoperative clinics: demographic data, medical history, clinical symptoms attributed to the Essure device, time between Essure sterilization and early symptoms, time between the beginning of symptoms and surgical removal. Follow-up visits have benne scheduled at one month and three months post-operation. The evolution of symptoms was collected during the follow-up visit at three months based on clinical reports and a dedicated questionnaire. Evaluation of Quality of life have been evaluated thanks to SF36 and HAD questionnaires. Alle these patients will be contacted by phone call to assess to evolution of symptoms and to complete SF 36 and HAD questionnaires.\n\nHypothesis : Recovery of symptoms due to ESSURE device and improvement of quality of life after surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women who underwent Essure\\_ device removal by salpingectomy, between February 2017 and August 2018.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* age \\>18 years old\n* symptoms related to ESSURE device\n* salpingectomy for ESSURE removal\n\nExclusion criteria:\n\n\\- Exclusion criteria were failure to perform a complete removal of the Essure and second surgery to remove fragments left behind from a previous procedure.'}, 'identificationModule': {'nctId': 'NCT04779658', 'acronym': 'ESSURE', 'briefTitle': 'Laparoscopic Essure Device Removal', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Essure Removal for Device-attributed Symptoms: Quality of Life Evaluation Before and After Surgical Removal', 'orgStudyIdInfo': {'id': 'RECHMPL21_0087'}}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'RATHAT GAUTHIER, MD', 'role': 'CONTACT', 'email': 'g-rathat@chu-montpellier.fr', 'phone': '467336421', 'phoneExt': '33'}, {'name': 'DURAES Martha', 'role': 'CONTACT', 'email': 'duraesmartha@gmail.com', 'phone': '631329158', 'phoneExt': '33'}], 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'centralContacts': [{'name': 'GAUTHIER RATHAT', 'role': 'CONTACT', 'email': 'g-rathat@chu-montpllier.fr', 'phone': '467336421', 'phoneExt': '33'}, {'name': 'Martha DURAES, MD', 'role': 'CONTACT', 'email': 'duraesmartha@gmail.com', 'phone': '631329158', 'phoneExt': '33'}], 'overallOfficials': [{'name': 'Martha DURAES, Md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}