Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A02010-45 | Other Identifier | ID-RCB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 Marketed in 2002, ESSURE® contraceptive implants were withdrawn from the French market in 2017 (and worldwide in 2017 and 2018) following the observation in certain patients of polymorphic and non-specific gynecological and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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Essure Group | Experimental | Patients requiring removal of the Essure® contraceptive implant |
|
| Control Group | Active Comparator | Control patients who should benefit from a salpingectomy with or without hysterectomy for a benign indication |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic resonance imaging- Positron Emission Tomography (MRI-PET) examination | Device | An MRI-PET examination will be carried out pre-operatively and at 6 months for the first 20 patients with Essure® and pre-operatively for the first 10 control patients presenting the selection criteria. The duration of each acquisition will be approximately 2 hours. Upon arrival, participants will be greeted by electroradiography technicians. A venous catheter will be placed in a vein in the right or left arm. Participants will be installed in the hybrid MRI-PET imager. The injection of [11C]PK11195 will take place in the MRI-PET acquisition room. Recording of functional neuroimaging data will begin immediately after intravenous injection of [11C]PK11195 and will last for 70 minutes in a resting state. At the end of the examination, the venous catheter will be removed and the visit will be over. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with improvement in symptoms Percentage of patients with improvement in symptoms | Percentage of patients with a score of 1, 2 or 3 (corresponding to improvement in symptoms) on the Patient Global Impression of Improvement (PGI-I) scale. The PGI-I is a transition scale that is a single question asking the patient to rate their symptoms now, as compared with how it was prior to before beginning treatment on a scale from 1 = Very much better to 7 = Very much worse. | At 2 months after surgical intervention (removal of the Essure® contraceptive implant) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with improvement in symptoms | Percentage of patients with a score of 1, 2 or 3 (corresponding to improvement in symptoms) on the PGI-I scale. The PGI-I is a transition scale that is a single question asking the patient to rate their symptoms now, as compared with how it was prior to before beginning treatment on a scale from 1 = Very much better to 7 = Very much worse. | up 5 years |
Not provided
ESSURE Group:
Selection for MRI-PET examination:
Control group:
Selection for MRI-PET examination:
age matching (+/- 5 years) with Essure® patients who have had an MRI-PET
matching on surgical technique with Essure® patients who have had an MRI-PET: salpingectomy with or without hysterectomy
no analgesic treatment, or treatment stopped 48 hours before the examination
no psychotropic treatment (anxiolytics, hypnotics (sleeping pills), antidepressants, mood stabilizers, neuroleptics)
patient having given free, informed and signed consent
ESSURE Group:
Selection for MRI-PET examination:
Control Group :
Selection for MRI-PET examination:
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gautier Chene, PU,PH | Contact | 0472355870 | +33 | gautier.chene@chu-lyon.fr |
| Stéphanie MORET | Contact | 0472355878 | +33 | stephanie.moret@chu-lyon.fr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Angers | Not yet recruiting | Angers | 49933 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| blood sample | Biological | Patients with Essure : Blood sample pre-operatively (20 mL) and at 2 months (10 mL) and 12 months (5 mL). Control patients : Blood sample pre-operatively (20 mL) |
|
| urine collection | Biological | Patients with Essure : urine collection pre-operatively (10 mL) and at 2 months (10 mL) and 12 months (10 mL). Control patients : urine collection pre-operatively (10 mL) |
|
| Collection of a lock of hair | Biological | Patients with Essure : Collection of a lock of hair pre-operatively and at 12 months Control patients : Collection of a lock of hair pre-operatively |
|
| questionnaire | Other | Questionnaires pre-operatively (except PGI-I) and at 2, 6, 12 months then twice a year up to 5 years for patients with Essure, and pre-operatively (except PGI-I) and at 2 months for control patients :
|
|
| Short Form 12 (SF-12) score | quality of life with assessment of the physical dimension (from 9.94738 to 70.02246) and the mental dimension (from 5.89058 to 71.96825). For each, the average in the general population is 50. | up 5 years |
| Fibromyalgia Impact Questionnaire (FIQ) score | quality of life of women with fibromyalgia symptoms (from 0 : no symptoms to 100 : important symptoms) | up 5 years |
| Hospital Anxiety and Depression scale (HADS) score | anxiety dimension and depressive dimension (for each dimension, from 0 : no symptom to 21 : certain symptomatology) | up 5 years |
| Multidimensional Fatigue Inventory (MFI)-20 score | Fatigue assessment according to 5 dimensions (General Fatigue, Physical and Mental Fatigue, Reduction in Motivation and Activities) (score from 20 : no fatigue to 100 : important fatigue) | up 5 years |
| Visual analog scale (VAS) score | pain assessment (from 0 : no pain to 100 : unbearable pain) | up 5 years |
| Questionnaire Douleur St-Antoine (QDSA) score | Assessment of sensory impact of pain (from 0: no pain to 36: important impact) and emotional impact of pain (from 0: no pain to 28 : important impact). The global score ranges from 0 to 64. | up 5 years |
| Female Sexual Function Index (FSFI) score | quality of sexual life (from 2 to 36). A low score indicates poorer sexual function. | up 5 years |
| Higham questionnaires | The Higham score is used to quantify blood loss during menstruation. A score ≥ 100 indicates a loss of 80 ml or more, which defines menorrhagia. A score ≥ 150 may indicate an indication for surgery for menometrorrhagia. | up 5 years |
| visual analog scale (VAS) score | Assessment by the surgeon of the difficulty of performing the ablation on a visual analog scale : from 0 (very easy) to 100 mm (very difficult) | During surgical intervention |
| Duration of the procedure | Duration of the procedure (calculated between incision and closure) in number of minutes | During surgical intervention |
| Complications | Number and types of per- and post-operative complications | Up to 2 months after the operation |
| characterization of the mechanical behavior of the implant | characterization of the mechanical behavior of the Essure® device implant will be assessed during tensile breakage and thermal breakage for its two parts (internal part and external part) | During surgical intervention |
| determination of the associated mechanical stress levels determination of the associated mechanical stress levels | determination of the associated mechanical stress levels of the Essure® device implant will be assessed during tensile breakage and thermal breakage for its two parts (internal part and external part) | During surgical intervention |
| quantification of the factors influencing these levels of mechanical stress | quantification of the factors influencing these levels of mechanical stress of the Essure® device implant will be assessed during tensile breakage and thermal breakage for its two parts (internal part and external part) | During surgical intervention |
| thermal resistance | The thermal resistance of the Essure® device implant during coagulations/electrical sections will be assessed. | During surgical intervention |
| risk of degradation | The risk of degradation depending on the temperature f the Essure® device implant used during coagulations/electrical sections will be assessed. | During surgical intervention |
| Concentrations of titanium constituting the Essure® implant | Concentrations of titanium constituting the Essure® implant in the peritoneal fluid, in the surgical piece, in the urine, in the blood, in the appendages (hair). | up 12 months after surgical intervention |
| Concentrations of nickel constituting the Essure® implant | Concentrations of nickel constituting the Essure® implant in the peritoneal fluid, in the surgical piece, in the urine, in the blood, in the appendages (hair). | up 12 months after surgical intervention |
| Concentrations of chromium constituting the Essure® implant | Concentrations of chromium constituting the Essure® implant in the peritoneal fluid, in the surgical piece, in the urine, in the blood, in the appendages (hair). | up 12 months after surgical intervention |
| Concentrations of tin constituting the Essure® implant | Concentrations of tin constituting the Essure® implant in the peritoneal fluid, in the surgical piece, in the urine, in the blood, in the appendages (hair). | up 12 months after surgical intervention |
| Concentrations of platinum constituting the Essure® implant | Concentrations of platinum constituting the Essure® implant in the peritoneal fluid, in the surgical piece, in the urine, in the blood, in the appendages (hair). | up 12 months after surgical intervention |
| Concentrations of iridium constituting the Essure® implant | Concentrations of iridium constituting the Essure® implant in the peritoneal fluid, in the surgical piece, in the urine, in the blood, in the appendages (hair). | up 12 months after surgical intervention |
| Concentrations of molybdenum constituting the Essure® implant | Concentrations of molybdenum constituting the Essure® implant in the peritoneal fluid, in the surgical piece, in the urine, in the blood, in the appendages (hair). | up 12 months after surgical intervention |
| Concentrations of manganese constituting the Essure® implant | Concentrations of manganese constituting the Essure® implant in the peritoneal fluid, in the surgical piece, in the urine, in the blood, in the appendages (hair). | up 12 months after surgical intervention |
| Concentrations of tungsten constituting the Essure® implant | Concentrations of tungsten constituting the Essure® implant in the peritoneal fluid, in the surgical piece, in the urine, in the blood, in the appendages (hair). | up 12 months after surgical intervention |
| Concentrations of silver constituting the Essure® implant | Concentrations of silver constituting the Essure® implant in the peritoneal fluid, in the surgical piece, in the urine, in the blood, in the appendages (hair). | up 12 months after surgical intervention |
| Concentrations of iron constituting the Essure® implant | Concentrations of iron constituting the Essure® implant in the peritoneal fluid, in the surgical piece, in the urine, in the blood, in the appendages (hair). | up 12 months after surgical intervention |
| concentration of pro-inflammatory cytokines | concentration of pro-inflammatory cytokines in the blood will be assessed | Up 2 months after surgical intervention |
| expression profile of miRNAs | Expression profile of miRNAs in the peritoneal fluid will be assessed. | Up 2 months after surgical intervention |
| activated T lymphocyte profile | activated T lymphocyte profile in blood will be assessed. | Up 2 months after surgical intervention |
| analysis of inflammatory pathway mRNAs | analysis of inflammatory pathway mRNAs (nanostring® technology) in a pathology sample from the surgical specimen will be assessed. | Up 2 months after surgical intervention |
| Percentage of detection of Human Leukocyte Antigen | Percentage of detection of Human Leukocyte Antigen (HLA)-DR53 (DRB4∗01) associated with nickel allergies in blood will be assessed. | Up 2 months after surgical intervention |
| Functional brain functions | MRI-PET (Magnetic resonance imaging- Positron Emission Tomography) examination :
| up 6 months after Surgical intervention |
| Hôpital Femme Mère Enfant (Hospices Civils de Lyon) | Recruiting | Bron | 69677 | France |
|
| Hôpital Bicêtre | Not yet recruiting | Le Kremlin-Bicêtre | 94275 | France |
|
| Hôpital Jeanne de Flandres | Not yet recruiting | Lille | 59037 | France |
|
| Hôpital de La Conception | Not yet recruiting | Marseille | 13005 | France |
|
| Institut Mère Enfant Alix de Champagne, CHU Reims | Not yet recruiting | Reims | 51092 | France |
|
| CHU de Rouen | Not yet recruiting | Rouen | 76000 | France |
|
| Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg | Not yet recruiting | Strasbourg | 67200 | France |
|
| Hôpital Paule de Viguier, CHU de Toulouse | Not yet recruiting | Toulouse | 31059 | France |
|
| Hôpital André Mignot, Centre Hospitalier de Versailles | Not yet recruiting | Versailles | 78157 | France |
|
| ID | Term |
|---|---|
| D010808 | Physical Examination |
| D001800 | Blood Specimen Collection |
| D059349 | Urine Specimen Collection |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
Not provided
Not provided