Improvement of Symptoms After Removal of the Essure® Contraceptive Implant

NARecruitingINTERVENTIONAL
Enrollment

444

Participants

Timeline

Start Date

February 17, 2025

Primary Completion Date

April 17, 2032

Study Completion Date

February 17, 2037

Conditions
Implant ComplicationContraceptive Device; Complications
Interventions
DEVICE

Magnetic resonance imaging- Positron Emission Tomography (MRI-PET) examination

"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."

BIOLOGICAL

blood sample

"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)"

BIOLOGICAL

urine collection

"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)"

BIOLOGICAL

Collection of a lock of hair

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

OTHER

questionnaire

"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 :~* PGI-I: symptom improvement score~* SF-12: quality of life with physical and mental dimension.~* FIQ: quality of life of women with fibromyalgia symptoms~* HADS: anxiety and depressive dimension~* MFI-20: fatigue according to 5 dimensions )~* VAS : pain assessment~* QDSA: assessment of sensory and emotional impact of pain~* FSFI : quality of sexual life~* Higham score"

Trial Locations (10)

13005

NOT_YET_RECRUITING

Hôpital de La Conception, Marseille

31059

NOT_YET_RECRUITING

Hôpital Paule de Viguier, CHU de Toulouse, Toulouse

49933

NOT_YET_RECRUITING

CHU de Angers, Angers

51092

NOT_YET_RECRUITING

Institut Mère Enfant Alix de Champagne, CHU Reims, Reims

59037

NOT_YET_RECRUITING

Hôpital Jeanne de Flandres, Lille

67200

NOT_YET_RECRUITING

Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg, Strasbourg

69677

RECRUITING

Hôpital Femme Mère Enfant (Hospices Civils de Lyon), Bron

76000

NOT_YET_RECRUITING

CHU de Rouen, Rouen

78157

NOT_YET_RECRUITING

Hôpital André Mignot, Centre Hospitalier de Versailles, Versailles

94275

NOT_YET_RECRUITING

Hôpital Bicêtre, Le Kremlin-Bicêtre

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER