Actively Recruiting
Prospective Multicenter Study of the Improvement of Symptoms After Removal of the Essure4 Contraceptive Implant
Led by Hospices Civils de Lyon · Updated on 2026-04-13
444
Participants Needed
10
Research Sites
252 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the improvement of symptoms in adult women who have the Essure4 contraceptive implant, which was withdrawn from the market due to reports of various gynecological and other symptoms. This prospective multicenter study aims to assess symptom changes after removal of the implant, understand possible biological mechanisms, and evaluate surgical techniques to reduce complications. The study also investigates potential inflammatory and autoimmune effects linked to metallic elements from the implant. Participants include women with at least one Essure4 implant who need surgical removal due to symptoms, and a control group of women undergoing salpingectomy with or without hysterectomy for benign reasons. Surgeries may use vaginal, laparoscopic, robotic, or VNotes approaches. The study includes a subgroup undergoing MRI-PET scans before and 6 months after surgery to explore neuroinflammation. Blood, urine, and hair samples are collected at various timepoints to assess metal concentrations and inflammatory markers. During the study, participants complete questionnaires assessing symptoms, quality of life, fatigue, anxiety, depression, pain, and sexual function before surgery and periodically for up to 5 years. Researchers will measure symptom improvement at 2 months post-surgery as the primary outcome, with longer-term follow-up to monitor changes and safety. The study also evaluates surgical procedure details, implant mechanical properties, and biological markers to better understand the implant’s effects and guide future treatments.
CONDITIONS
Brief Title
Improvement of Symptoms After Removal of the Essure® Contraceptive Implant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Woman aged 35 to 75 years
- Has at least one Essure4 implant
- Scheduled for surgical removal of the Essure4 implant(s) due to symptoms
- Planned surgery via vaginal route, laparoscopy, robotic surgery, or Transvaginal natural orifice transluminal endoscopic surgery (VNotes)
- Provided free, informed, and signed consent
- For control group: woman aged 35 to 75 years
- Scheduled for salpingectomy with or without hysterectomy for benign reasons
- Planned surgery via vaginal route, laparoscopy, robotic surgery, or VNotes
- Provided free, informed, and signed consent
You will not qualify if you...
- Asymptomatic patient with Essure4 implant
- Planned intervention by laparotomy
- Exposure to other heavy metals (metallic orthopedic equipment, coronary stent, or tubal ligation clip)
- Unable to understand the information given
- Persons deprived of liberty by judicial or administrative decision
- Undergoing psychiatric care
- Admitted to health or social establishment for purposes other than research
- Adults under legal protection measures (guardianship, curatorship)
- Not affiliated with a social security scheme or similar
- Participating in another interventional research that may interfere
- Current pregnancy (control group)
- Patient with cancer (control group)
- Patient with prior Essure4 implant removal (control group)
- Claustrophobia (for MRI-PET subgroup)
- Unacceptable radiological dosimetry in past year (for MRI-PET subgroup)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo surgical removal of the Essure® contraceptive implant or salpingectomy with or without hysterectomy for benign reasons.
1 visit (in-person)
Duration - Pre-operative and 6 months post-surgery
Participants undergo MRI-PET examinations pre-operatively and at 6 months (for selected subgroups) to assess brain function.
1 to 2 visits (in-person) depending on subgroup
Duration - Pre-operatively up to 12 months post-surgery
Participants provide blood samples, urine collections, and hair samples at specified times before and after surgery to monitor biological markers.
3 visits (in-person) at pre-operative, 2 months, and 12 months
Duration - Pre-operatively up to 5 years post-surgery
Participants complete various questionnaires assessing symptoms, quality of life, pain, fatigue, anxiety, depression, and sexual function before surgery and regularly up to 5 years after surgery.
Multiple visits including pre-operative, 2, 6, 12 months, then twice yearly up to 5 years
Duration - Up to 5 years post-surgery
Participants are monitored for symptom improvement, complications, and biological changes up to 5 years after surgery.
Regular assessments during questionnaire visits
Trial Site Locations
Total: 10 locations
1
CHU de Angers
Angers, France, 49933
Not Yet Recruiting
2
Hôpital Femme Mère Enfant (Hospices Civils de Lyon)
Bron, France, 69677
Actively Recruiting
3
Hôpital Bicêtre
Le Kremlin-Bicêtre, France, 94275
Not Yet Recruiting
4
Hôpital Jeanne de Flandres
Lille, France, 59037
Not Yet Recruiting
5
Hôpital de La Conception
Marseille, France, 13005
Not Yet Recruiting
6
Institut Mère Enfant Alix de Champagne, CHU Reims
Reims, France, 51092
Not Yet Recruiting
7
CHU de Rouen
Rouen, France, 76000
Not Yet Recruiting
8
Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67200
Not Yet Recruiting
9
Hôpital Paule de Viguier, CHU de Toulouse
Toulouse, France, 31059
Not Yet Recruiting
10
Hôpital André Mignot, Centre Hospitalier de Versailles
Versailles, France, 78157
Not Yet Recruiting
Research Team
G
Gautier Chene, PU,PH
S
Stéphanie MORET
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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