protocolSection identificationModule nctId: NCT06355713, orgStudyIdInfo id: 69HCL23_0899, secondaryIdInfos id: 2023-A02010-45, type: OTHER, domain: ID-RCB, briefTitle: Improvement of Symptoms After Removal of the Essure® Contraceptive Implant, acronym: ABLES, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2031-08-01, completionDateStruct date: 2036-06-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Hospices Civils de Lyon, class: OTHER, descriptionModule briefSummary: ESSURE® is an implantable medical device for definitive and irreversible sterilization indicated for adult women of childbearing age. These implants are inserted into the fallopian tubes by hysteroscopy. Marketed in 2002, ESSURE® contraceptive implants were withdrawn from the French market in 2017 (and worldwide in 2017 and 2018) following the observation in certain patients of polymorphic and non-specific gynecological and extra-gynecological symptoms. Studies with small numbers and short-term follow-up have shown a significant improvement in these symptoms after implant explantation. This constitutes a real public health problem since according to the report of the EPI-PHARE Scientific Interest Group, 198,000 French women have these implants and only 30,000 of them, or 15%, have been explanted, knowing that explantation of ESSURE® implants is recommended only in symptomatic patients. A large number of these patients, presenting symptoms, have not yet been treated for an explant.The physiopathological mechanism(s) is (are) not yet determined but several arguments are in favor of a dissemination of metallic elements contained in these implants whose accumulation could lead to inflammatory and/or allergic and/or autoimmune phenomena.Carrying out a prospective study with long-term longitudinal follow-up appears essential to precisely assess the degree of improvement in the symptoms and quality of life of these patients, determine the most appropriate surgical techniques, and understand the pathophysiological mechanisms that may result in the implementation of specific treatments and relevant markers. From a surgical point of view, there is a real risk of fracture of implants whatever the type of intervention performed: study the biomechanical properties of implants with a view to characterizing their behavior to mechanical rupture but also their thermal resistance in an objective manner seems essential to limit the risk of fracture and help to inform the patient about the surgical technique proposed for explantation. From a biological point of view, the dosage of the metallic elements constituting ESSURE® implants and potentially toxic ones could make it possible to objectify the release of these metallic elements in the body. Analysis of pro-inflammatory cytokines, micro-RNAs (miRNA), quantitative analysis of inflammatory pathway messenger ribonucleic acid (mRNAs) (NanoString technology) and analysis of neuroinflammation by functional imaging should make it possible to explore potential pathophysiological mechanisms. This study responds to a significant request from patient associations., conditionsModule conditions: Implant Complication, conditions: Contraceptive Device; Complications, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 444, type: ESTIMATED, armsInterventionsModule interventions name: Magnetic resonance imaging- Positron Emission Tomography (MRI-PET) examination, interventions name: blood sample, interventions name: urine collection, interventions name: Collection of a lock of hair, interventions name: questionnaire, outcomesModule primaryOutcomes measure: Percentage of patients with improvement in symptoms Percentage of patients with improvement in symptoms, secondaryOutcomes measure: Percentage of patients with improvement in symptoms, secondaryOutcomes measure: Short Form 12 (SF-12) score, secondaryOutcomes measure: Fibromyalgia Impact Questionnaire (FIQ) score, secondaryOutcomes measure: Hospital Anxiety and Depression scale (HADS) score, secondaryOutcomes measure: Multidimensional Fatigue Inventory (MFI)-20 score, secondaryOutcomes measure: Visual analog scale (VAS) score, secondaryOutcomes measure: Questionnaire Douleur St-Antoine (QDSA) score, secondaryOutcomes measure: Female Sexual Function Index (FSFI) score, secondaryOutcomes measure: Higham questionnaires, secondaryOutcomes measure: visual analog scale (VAS) score, secondaryOutcomes measure: Duration of the procedure, secondaryOutcomes measure: Complications, secondaryOutcomes measure: characterization of the mechanical behavior of the implant, secondaryOutcomes measure: determination of the associated mechanical stress levels determination of the associated mechanical stress levels, secondaryOutcomes measure: quantification of the factors influencing these levels of mechanical stress, secondaryOutcomes measure: thermal resistance, secondaryOutcomes measure: risk of degradation, secondaryOutcomes measure: Concentrations of titanium constituting the Essure® implant, secondaryOutcomes measure: Concentrations of nickel constituting the Essure® implant, secondaryOutcomes measure: Concentrations of chromium constituting the Essure® implant, secondaryOutcomes measure: Concentrations of tin constituting the Essure® implant, secondaryOutcomes measure: Concentrations of platinum constituting the Essure® implant, secondaryOutcomes measure: Concentrations of iridium constituting the Essure® implant, secondaryOutcomes measure: Concentrations of molybdenum constituting the Essure® implant, secondaryOutcomes measure: Concentrations of manganese constituting the Essure® implant, secondaryOutcomes measure: Concentrations of tungsten constituting the Essure® implant, secondaryOutcomes measure: Concentrations of silver constituting the Essure® implant, secondaryOutcomes measure: Concentrations of iron constituting the Essure® implant, secondaryOutcomes measure: concentration of pro-inflammatory cytokines, secondaryOutcomes measure: expression profile of miRNAs, secondaryOutcomes measure: activated T lymphocyte profile, secondaryOutcomes measure: analysis of inflammatory pathway mRNAs, secondaryOutcomes measure: Percentage of detection of Human Leukocyte Antigen, secondaryOutcomes measure: Functional brain functions, eligibilityModule sex: FEMALE, minimumAge: 35 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU de Angers, city: Angers, zip: 49933, country: France, contacts name: Guillaume Legendre, PU,PH, role: CONTACT, phone: 0241354635, phoneExt: +33, email: guillaume.legendre@chu-angers.fr, contacts name: Guillaume Legendre, PU,PH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.46667, lon: -0.55, locations facility: Hôpital Femme Mère Enfant (Hospices Civils de Lyon), city: Bron, zip: 69677, country: France, contacts name: Gautier Chene, PU,PH, role: CONTACT, phone: 0472355870, phoneExt: +33, email: gautier.chene@chu-lyon.fr, contacts name: Gautier Chene, PU,PH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.73333, lon: 4.91667, locations facility: Hôpital Bicêtre, city: Le Kremlin-Bicêtre, zip: 94275, country: France, contacts name: Perrine CAPMAS, PU,PH, role: CONTACT, phone: 0145217714, phoneExt: +33, email: perrine.capmas@aphp.fr, contacts name: Perrine CAPMAS, PU,PH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.81471, lon: 2.36073, locations facility: Hôpital Jeanne de Flandres, city: Lille, zip: 59037, country: France, contacts name: Victoire Delporte, PU,PH, role: CONTACT, phone: 0320446641, phoneExt: +33, email: victoire.delporte@chu-lille.fr, contacts name: Victoire Delporte, PU,PH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.63297, lon: 3.05858, locations facility: Hôpital de La Conception, city: Marseille, zip: 13005, country: France, contacts name: Aubert Agostini, PU,PH, role: CONTACT, phone: 0491383702, phoneExt: +33, email: Aubert.AGOSTINI@ap-hm.fr, contacts name: Aubert Agostini, PU,PH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.29551, lon: 5.38958, locations facility: Institut Mère Enfant Alix de Champagne, CHU Reims, city: Reims, zip: 51092, country: France, contacts name: Olivier Graesslin, PU,PH, role: CONTACT, phone: 0326783517, phoneExt: +33, email: ograesslin@chu-reims.fr, contacts name: Olivier Graesslin, PU,PH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.25, lon: 4.03333, locations facility: CHU de Rouen, city: Rouen, zip: 76000, country: France, contacts name: Patrice Crochet, PU,PH, role: CONTACT, phone: 0232881054, phoneExt: +33, email: patrice.crochet@chu-rouen.fr, contacts name: Patrice Crochet, PU,PH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.44313, lon: 1.09932, locations facility: Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg, city: Strasbourg, zip: 67200, country: France, contacts name: Thomas Boisrame, PU,PH, role: CONTACT, phone: 0388127458, phoneExt: +33, email: thomas.boisrame@chru-strasbourg.fr, contacts name: Thomas Boisrame, PU,PH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.58392, lon: 7.74553, locations facility: Hôpital Paule de Viguier, CHU de Toulouse, city: Toulouse, zip: 31059, country: France, contacts name: Yann Tanguy Le Gac, PU,PH, role: CONTACT, phone: 0567771105, phoneExt: +33, email: tanguylegac.y@chu-toulouse.fr, contacts name: Yann Tanguy Le Gac, PU,PH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.60426, lon: 1.44367, locations facility: Hôpital André Mignot, Centre Hospitalier de Versailles, city: Versailles, zip: 78157, country: France, contacts name: Pierre Panel, PU,PH, role: CONTACT, phone: 0139638936, phoneExt: +33, email: ppanel@ch-versailles.fr, contacts name: Pierre Panel, PU,PH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.8, lon: 2.13333, hasResults: False