Improving symptoms by removing the Essure contraceptive implant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of removing the Essure® contraceptive implant in women aged 35 to 75 who are experiencing symptoms related to the device. The study aims to assess symptom improvement following explantation through various surgical methods, including laparoscopy and robotic surgery. Participants will undergo MRI-PET examinations, blood and urine tests, and complete questionnaires to evaluate their health status pre- and post-surgery. The trial addresses a significant public health issue, as many women with these implants have not received the necessary treatment for their symptoms.

Why it matters

Who can join: the full rules

* 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

Where it's running

• Hôpital Femme Mère Enfant (Hospices Civils de Lyon)
  Bron, France Recruiting
• CHU de Angers
  Angers, France Not yet recruiting
• Hôpital Bicêtre
  Le Kremlin-Bicêtre, France Not yet recruiting
• Hôpital Jeanne de Flandres
  Lille, France Not yet recruiting
• Hôpital de La Conception
  Marseille, France Not yet recruiting
• Institut Mère Enfant Alix de Champagne, CHU Reims
  Reims, France Not yet recruiting

Study contacts

• Study coordinator: Gautier Chene, PU,PH
• Email: gautier.chene@chu-lyon.fr
• Phone: 0472355870

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.