Hope for women with essure implant symptoms: study tracks recovery after removal
NCT ID NCT06355713
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study follows 444 women who had Essure contraceptive implants removed due to symptoms like pain or other health issues. Researchers want to see how much symptoms improve after removal and understand why some women had problems. The goal is to help doctors choose the best removal methods and improve patient care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 444 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Feb 2037
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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35 to 75 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
10 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU de Angers
NOT_YET_RECRUITINGAngers, 49933, France
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CHU de Rouen
NOT_YET_RECRUITINGRouen, 76000, France
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Hôpital André Mignot, Centre Hospitalier de Versailles
NOT_YET_RECRUITINGVersailles, 78157, France
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Hôpital Bicêtre
NOT_YET_RECRUITINGLe Kremlin-Bicêtre, 94275, France
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Hôpital Femme Mère Enfant (Hospices Civils de Lyon)
RECRUITINGBron, 69677, France
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Hôpital Jeanne de Flandres
NOT_YET_RECRUITINGLille, 59037, France
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Hôpital Paule de Viguier, CHU de Toulouse
NOT_YET_RECRUITINGToulouse, 31059, France
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Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
NOT_YET_RECRUITINGStrasbourg, 67200, France
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Hôpital de La Conception
NOT_YET_RECRUITINGMarseille, 13005, France
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Institut Mère Enfant Alix de Champagne, CHU Reims
NOT_YET_RECRUITINGReims, 51092, France
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