Improving symptoms by removing the Essure contraceptive implant
Prospective Multicenter Study of the Improvement of Symptoms After Removal of the Essure® Contraceptive Implant
This study is testing if removing the Essure contraceptive implant can help women aged 35 to 75 who are having problems with the device feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 444 (estimated) |
| Ages | 35 Years to 75 Years |
| Sex | Female |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 10 sites (Angers and 9 other locations) |
| Trial ID | NCT06355713 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 35 to 75 with at least one Essure® implant who are symptomatic and scheduled for explantation.
Not a fit: Patients who do not have an Essure® implant or are asymptomatic may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide significant relief for women suffering from complications related to the Essure® implant.
How similar studies have performed: Previous studies have shown significant symptom improvement after explantation of the Essure® implant, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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 this trial is running
Angers and 9 other locations
- CHU de Angers — Angers, France (Not_yet_recruiting)
- Hôpital Femme Mère Enfant (Hospices Civils de Lyon) — Bron, France (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)
- CHU de Rouen — Rouen, France (Not_yet_recruiting)
- Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg — Strasbourg, France (Not_yet_recruiting)
- Hôpital Paule de Viguier, CHU de Toulouse — Toulouse, France (Not_yet_recruiting)
- Hôpital André Mignot, Centre Hospitalier de Versailles — Versailles, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Gautier Chene, PU,PH
- Email: gautier.chene@chu-lyon.fr
- Phone: 0472355870
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.