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Hope for women with essure implant symptoms: study tracks recovery after removal

NCT ID NCT06355713

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 444 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Feb 2037

An estimate. End dates often move.

Lead sponsor

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

35 to 75 years

Sex

Female participants only

Healthy volunteers

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

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.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • CHU de Angers

    NOT_YET_RECRUITING

    Angers, 49933, France

  • CHU de Rouen

    NOT_YET_RECRUITING

    Rouen, 76000, France

  • Hôpital André Mignot, Centre Hospitalier de Versailles

    NOT_YET_RECRUITING

    Versailles, 78157, France

  • Hôpital Bicêtre

    NOT_YET_RECRUITING

    Le Kremlin-Bicêtre, 94275, France

  • Hôpital Femme Mère Enfant (Hospices Civils de Lyon)

    RECRUITING

    Bron, 69677, France

  • Hôpital Jeanne de Flandres

    NOT_YET_RECRUITING

    Lille, 59037, France

  • Hôpital Paule de Viguier, CHU de Toulouse

    NOT_YET_RECRUITING

    Toulouse, 31059, France

  • Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg

    NOT_YET_RECRUITING

    Strasbourg, 67200, France

  • Hôpital de La Conception

    NOT_YET_RECRUITING

    Marseille, 13005, France

  • Institut Mère Enfant Alix de Champagne, CHU Reims

    NOT_YET_RECRUITING

    Reims, 51092, France

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