Phase
Condition
N/ATreatment
blood sample
questionnaire
Collection of a lock of hair
Clinical Study ID
Ages 35-75 Female
Study Summary
Eligibility Criteria
Inclusion
- Inclusion Criteria * :
ESSURE Group:
woman aged 35 to 75
patient with at least one Essure® implant
surgical intervention planned because the patient is symptomatic: removal of the Essure® implant(s)
planned intervention via vaginal route, laparoscopy, robotic surgery, or Transvaginal natural orifice transluminal endoscopic surgery (VNotes)
patient having given free, informed and signed consent
Selection for MRI-PET examination:
if the answer is "poor" or "bad" to the first question of the SF-12 pre-operatively
no 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
Control group:
woman aged 35 to 75
planned surgical intervention: salpingectomy with or without hysterectomy for benign indication
planned intervention via vaginal route, laparoscopy, robotic surgery, or VNotes
patient having given free, informed and signed consent
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
Exclusion Criteria * :
ESSURE Group:
asymptomatic patient
planned intervention by laparotomy
patient potentially exposed to other heavy metals: wearer of metallic orthopedic equipment (hip or knee prosthesis, etc.), wearer of coronary stent, or tubal ligation clip
inability to understand the information given
persons deprived of liberty by a judicial or administrative decision
people undergoing psychiatric care
people admitted to a health or social establishment for purposes other than research
adults subject to a legal protection measure (guardianship, curatorship)
people not affiliated to a social security scheme or beneficiaries of a similar scheme
person participating in another interventional research that may interfere with the research
Selection for MRI-PET examination:
claustrophobia
dosimetry of all radiological examinations over the past year not acceptable
Control Group :
current pregnancy
patient with cancer
patient who has already had an Essure® implant removed
patient potentially exposed to heavy metals: wearer of metallic orthopedic equipment (hip or knee prosthesis, etc.), wearer of coronary stent, or tubal ligation clip
planned intervention by laparotomy
inability to understand the information given
persons deprived of liberty by a judicial or administrative decision
people undergoing psychiatric care
people admitted to a health or social establishment for purposes other than research
adults subject to a legal protection measure (guardianship, curatorship)
people not affiliated to a social security scheme or beneficiaries of a similar scheme
person participating in another interventional research that may interfere with the research
Selection for MRI-PET examination:
claustrophobia
dosimetry of all radiological examinations over the past year not acceptable
Study Design
Connect with a study center
CHU de Angers
Angers, 49933
FranceSite Not Available
Hôpital Femme Mère Enfant (Hospices Civils de Lyon)
Bron, 69677
FranceActive - Recruiting
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94275
FranceSite Not Available
Hôpital Jeanne de Flandres
Lille, 59037
FranceSite Not Available
Hôpital de La Conception
Marseille, 13005
FranceSite Not Available
Institut Mère Enfant Alix de Champagne, CHU Reims
Reims, 51092
FranceSite Not Available
CHU de Rouen
Rouen, 76000
FranceSite Not Available
Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67200
FranceSite Not Available
Hôpital Paule de Viguier, CHU de Toulouse
Toulouse, 31059
FranceSite Not Available
Hôpital André Mignot, Centre Hospitalier de Versailles
Versailles, 78157
FranceSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.