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Implant ComplicationABLESNCT06355713

Improvement of Symptoms After Removal of the Essure® Contraceptive Implant

A study testing Magnetic resonance imaging- Positron Emission Tomography (MRI-PET) examination, blood sample and urine collection in people with Implant Complication and Contraceptive Device; Complications, run by Hospices Civils de Lyon at 10 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

ESSURE® is an implantable medical device for definitive and irreversible sterilization indicated for adult women of childbearing age. These implants are inserted into the fallopian tubes by hysteroscopy. Read more about this study

Who is it for?
Ages 35 to 75 years, women only
What is being tested?
Magnetic resonance imaging- Positron Emission Tomography (MRI-PET) examination, blood sample and urine collection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
444 participants
Where
10 sitesFrance
Study dates
17 Feb 2025to 17 Feb 2037
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 23Show fewer
  • 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

Who cannot join

  • 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
Show all 30Show fewer
  • 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

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Gautier Chene, PU,PH contact

0472355870 ext. +33

gautier.chene@chu-lyon.fr

Stéphanie MORET contact

0472355878 ext. +33

stephanie.moret@chu-lyon.fr

10 sites in 1 country

France10 sites, 10 recruiting

  • CHU de Angers

    Angers, 49933

    Guillaume Legendre, PU,PH, 0241354635 ext. +33, guillaume.legendre@chu-angers.fr

    Guillaume Legendre, PU,PH

    Not yet recruiting

  • Hôpital Femme Mère Enfant (Hospices Civils de Lyon)

    Bron, 69677

    Gautier Chene, PU,PH, 0472355870 ext. +33, gautier.chene@chu-lyon.fr

    Gautier Chene, PU,PH

    Recruiting

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94275

    Perrine CAPMAS, PU,PH, 0145217714 ext. +33, perrine.capmas@aphp.fr

    Perrine CAPMAS, PU,PH

    Not yet recruiting

  • Hôpital Jeanne de Flandres

    Lille, 59037

    Victoire Delporte, PU,PH, 0320446641 ext. +33, victoire.delporte@chu-lille.fr

    Victoire Delporte, PU,PH

    Not yet recruiting

  • Hôpital de La Conception

    Marseille, 13005

    Aubert Agostini, PU,PH, 0491383702 ext. +33, Aubert.AGOSTINI@ap-hm.fr

    Aubert Agostini, PU,PH

    Not yet recruiting

  • Institut Mère Enfant Alix de Champagne, CHU Reims

    Reims, 51092

    Olivier Graesslin, PU,PH, 0326783517 ext. +33, ograesslin@chu-reims.fr

    Olivier Graesslin, PU,PH

    Not yet recruiting

  • CHU de Rouen

    Rouen, 76000

    Patrice Crochet, PU,PH, 0232881054 ext. +33, patrice.crochet@chu-rouen.fr

    Patrice Crochet, PU,PH

    Not yet recruiting

  • Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67200

    Thomas Boisrame, PU,PH, 0388127458 ext. +33, thomas.boisrame@chru-strasbourg.fr

    Thomas Boisrame, PU,PH

    Not yet recruiting

  • Hôpital Paule de Viguier, CHU de Toulouse

    Toulouse, 31059

    Yann Tanguy Le Gac, PU,PH, 0567771105 ext. +33, tanguylegac.y@chu-toulouse.fr

    Yann Tanguy Le Gac, PU,PH

    Not yet recruiting

  • Hôpital André Mignot, Centre Hospitalier de Versailles

    Versailles, 78157

    Pierre Panel, PU,PH, 0139638936 ext. +33, ppanel@ch-versailles.fr

    Pierre Panel, PU,PH

    Not yet recruiting

Other trials in France

About this study

Official title: Prospective Multicenter Study of the Improvement of Symptoms After Removal of the Essure® Contraceptive Implant

ESSURE® is an implantable medical device for definitive and irreversible sterilization indicated for adult women of childbearing age. These implants are inserted into the fallopian tubes by hysteroscopy. Marketed in 2002, ESSURE® contraceptive implants were withdrawn from the French market in 2017 (and worldwide in 2017 and 2018) following the observation in certain patients of polymorphic and non-specific gynecological and extra-gynecological symptoms. Studies with small numbers and short-term follow-up have shown a significant improvement in these symptoms after implant explantation. This constitutes a real public health problem since according to the report of the EPI-PHARE Scientific Interest Group, 198,000 French women have these implants and only 30,000 of them, or 15%, have been explanted, knowing that explantation of ESSURE® implants is recommended only in symptomatic patients. A large number of these patients, presenting symptoms, have not yet been treated for an explant.

The physiopathological mechanism(s) is (are) not yet determined but several arguments are in favor of a dissemination of metallic elements contained in these implants whose accumulation could lead to inflammatory and/or allergic and/or autoimmune phenomena.

Carrying out a prospective study with long-term longitudinal follow-up appears essential to precisely assess the degree of improvement in the symptoms and quality of life of these patients, determine the most appropriate surgical techniques, and understand the pathophysiological mechanisms that may result in the implementation of specific treatments and relevant markers. From a surgical point of view, there is a real risk of fracture of implants whatever the type of intervention performed: study the biomechanical properties of implants with a view to characterizing their behavior to mechanical rupture but also their thermal resistance in an objective manner seems essential to limit the risk of fracture and help to inform the patient about the surgical technique proposed for explantation. From a biological point of view, the dosage of the metallic elements constituting ESSURE® implants and potentially toxic ones could make it possible to objectify the release of these metallic elements in the body. Analysis of pro-inflammatory cytokines, micro-RNAs (miRNA), quantitative analysis of inflammatory pathway messenger ribonucleic acid (mRNAs) (NanoString technology) and analysis of neuroinflammation by functional imaging should make it possible to explore potential pathophysiological mechanisms. This study responds to a significant request from patient associations.

Being tested
Magnetic resonance imaging- Positron Emission Tomography (MRI-PET) examination, blood sample, urine collection, Collection of a lock of hair, questionnaire
Keywords
Essure implant, Contraceptive implant, Symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magnetic resonance imaging- Positron Emission Tomography (MRI-PET) examinationDevice

    An MRI-PET examination will be carried out pre-operatively and at 6 months for the first 20 patients with Essure® and pre-operatively for the first 10 control patients presenting the selection criteria.

    The duration of each acquisition will be approximately 2 hours. Upon arrival, participants will be greeted by electroradiography technicians. A venous catheter will be placed in a vein in the right or left arm. Participants will be installed in the hybrid MRI-PET imager. The injection of [11C]PK11195 will take place in the MRI-PET acquisition room. Recording of functional neuroimaging data will begin immediately after intravenous injection of [11C]PK11195 and will last for 70 minutes in a resting state.

    At the end of the examination, the venous catheter will be removed and the visit will be over.

  • blood sampleBiological

    Patients with Essure : Blood sample pre-operatively (20 mL) and at 2 months (10 mL) and 12 months (5 mL).

    Control patients : Blood sample pre-operatively (20 mL)

  • urine collectionBiological

    Patients with Essure : urine collection pre-operatively (10 mL) and at 2 months (10 mL) and 12 months (10 mL).

    Control patients : urine collection pre-operatively (10 mL)

  • Collection of a lock of hairBiological

    Patients with Essure : Collection of a lock of hair pre-operatively and at 12 months Control patients : Collection of a lock of hair pre-operatively

  • questionnaireOther

    Questionnaires pre-operatively (except PGI-I) and at 2, 6, 12 months then twice a year up to 5 years for patients with Essure, and pre-operatively (except PGI-I) and at 2 months for control patients :

    • PGI-I: symptom improvement score
    • SF-12: quality of life with physical and mental dimension.
    • FIQ: quality of life of women with fibromyalgia symptoms
    • HADS: anxiety and depressive dimension
    • MFI-20: fatigue according to 5 dimensions )
    • VAS : pain assessment
    • QDSA: assessment of sensory and emotional impact of pain
    • FSFI : quality of sexual life
    • Higham score
Study groups in NCT06355713
Study groupRoleWhat they receive
Essure GroupExperimentalPatients requiring removal of the Essure® contraceptive implant
Receives: Device: Magnetic resonance imaging- Positron Emission Tomography (MRI-PET) examination; Biological: blood sample; Biological: urine collection; Biological: Collection of a lock of hair; Other: questionnaire
Control GroupActive comparatorControl patients who should benefit from a salpingectomy with or without hysterectomy for a benign indication
Receives: Device: Magnetic resonance imaging- Positron Emission Tomography (MRI-PET) examination; Biological: blood sample; Biological: urine collection; Biological: Collection of a lock of hair; Other: questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patients with improvement in symptoms Percentage of patients with improvement in symptoms

    Percentage of patients with a score of 1, 2 or 3 (corresponding to improvement in symptoms) on the Patient Global Impression of Improvement (PGI-I) scale.

    The PGI-I is a transition scale that is a single question asking the patient to rate their symptoms now, as compared with how it was prior to before beginning treatment on a scale from 1 = Very much better to 7 = Very much worse.

    Measured: At 2 months after surgical intervention (removal of the Essure® contraceptive implant)

Secondary outcomes (34)

  1. Percentage of patients with improvement in symptoms

    Percentage of patients with a score of 1, 2 or 3 (corresponding to improvement in symptoms) on the PGI-I scale.

    The PGI-I is a transition scale that is a single question asking the patient to rate their symptoms now, as compared with how it was prior to before beginning treatment on a scale from 1 = Very much better to 7 = Very much worse.

    Measured: up 5 years

  2. Short Form 12 (SF-12) score

    quality of life with assessment of the physical dimension (from 9.94738 to 70.02246) and the mental dimension (from 5.89058 to 71.96825). For each, the average in the general population is 50.

    Measured: up 5 years

  3. Fibromyalgia Impact Questionnaire (FIQ) score

    quality of life of women with fibromyalgia symptoms (from 0 : no symptoms to 100 : important symptoms)

    Measured: up 5 years

  4. Hospital Anxiety and Depression scale (HADS) score

    anxiety dimension and depressive dimension (for each dimension, from 0 : no symptom to 21 : certain symptomatology)

    Measured: up 5 years

  5. Multidimensional Fatigue Inventory (MFI)-20 score

    Fatigue assessment according to 5 dimensions (General Fatigue, Physical and Mental Fatigue, Reduction in Motivation and Activities) (score from 20 : no fatigue to 100 : important fatigue)

    Measured: up 5 years

  6. Visual analog scale (VAS) score

    pain assessment (from 0 : no pain to 100 : unbearable pain)

    Measured: up 5 years

  7. Questionnaire Douleur St-Antoine (QDSA) score

    Assessment of sensory impact of pain (from 0: no pain to 36: important impact) and emotional impact of pain (from 0: no pain to 28 : important impact). The global score ranges from 0 to 64.

    Measured: up 5 years

  8. Female Sexual Function Index (FSFI) score

    quality of sexual life (from 2 to 36). A low score indicates poorer sexual function.

    Measured: up 5 years

  9. Higham questionnaires

    The Higham score is used to quantify blood loss during menstruation. A score ≥ 100 indicates a loss of 80 ml or more, which defines menorrhagia. A score ≥ 150 may indicate an indication for surgery for menometrorrhagia.

    Measured: up 5 years

  10. visual analog scale (VAS) score

    Assessment by the surgeon of the difficulty of performing the ablation on a visual analog scale : from 0 (very easy) to 100 mm (very difficult)

    Measured: During surgical intervention

  11. Duration of the procedure

    Duration of the procedure (calculated between incision and closure) in number of minutes

    Measured: During surgical intervention

  12. Complications

    Number and types of per- and post-operative complications

    Measured: Up to 2 months after the operation

  13. characterization of the mechanical behavior of the implant

    characterization of the mechanical behavior of the Essure® device implant will be assessed during tensile breakage and thermal breakage for its two parts (internal part and external part)

    Measured: During surgical intervention

  14. determination of the associated mechanical stress levels determination of the associated mechanical stress levels

    determination of the associated mechanical stress levels of the Essure® device implant will be assessed during tensile breakage and thermal breakage for its two parts (internal part and external part)

    Measured: During surgical intervention

  15. quantification of the factors influencing these levels of mechanical stress

    quantification of the factors influencing these levels of mechanical stress of the Essure® device implant will be assessed during tensile breakage and thermal breakage for its two parts (internal part and external part)

    Measured: During surgical intervention

  16. thermal resistance

    The thermal resistance of the Essure® device implant during coagulations/electrical sections will be assessed.

    Measured: During surgical intervention

  17. risk of degradation

    The risk of degradation depending on the temperature f the Essure® device implant used during coagulations/electrical sections will be assessed.

    Measured: During surgical intervention

  18. Concentrations of titanium constituting the Essure® implant

    Concentrations of titanium constituting the Essure® implant in the peritoneal fluid, in the surgical piece, in the urine, in the blood, in the appendages (hair).

    Measured: up 12 months after surgical intervention

  19. Concentrations of nickel constituting the Essure® implant

    Concentrations of nickel constituting the Essure® implant in the peritoneal fluid, in the surgical piece, in the urine, in the blood, in the appendages (hair).

    Measured: up 12 months after surgical intervention

  20. Concentrations of chromium constituting the Essure® implant

    Concentrations of chromium constituting the Essure® implant in the peritoneal fluid, in the surgical piece, in the urine, in the blood, in the appendages (hair).

    Measured: up 12 months after surgical intervention

  21. Concentrations of tin constituting the Essure® implant

    Concentrations of tin constituting the Essure® implant in the peritoneal fluid, in the surgical piece, in the urine, in the blood, in the appendages (hair).

    Measured: up 12 months after surgical intervention

  22. Concentrations of platinum constituting the Essure® implant

    Concentrations of platinum constituting the Essure® implant in the peritoneal fluid, in the surgical piece, in the urine, in the blood, in the appendages (hair).

    Measured: up 12 months after surgical intervention

  23. Concentrations of iridium constituting the Essure® implant

    Concentrations of iridium constituting the Essure® implant in the peritoneal fluid, in the surgical piece, in the urine, in the blood, in the appendages (hair).

    Measured: up 12 months after surgical intervention

  24. Concentrations of molybdenum constituting the Essure® implant

    Concentrations of molybdenum constituting the Essure® implant in the peritoneal fluid, in the surgical piece, in the urine, in the blood, in the appendages (hair).

    Measured: up 12 months after surgical intervention

  25. Concentrations of manganese constituting the Essure® implant

    Concentrations of manganese constituting the Essure® implant in the peritoneal fluid, in the surgical piece, in the urine, in the blood, in the appendages (hair).

    Measured: up 12 months after surgical intervention

  26. Concentrations of tungsten constituting the Essure® implant

    Concentrations of tungsten constituting the Essure® implant in the peritoneal fluid, in the surgical piece, in the urine, in the blood, in the appendages (hair).

    Measured: up 12 months after surgical intervention

  27. Concentrations of silver constituting the Essure® implant

    Concentrations of silver constituting the Essure® implant in the peritoneal fluid, in the surgical piece, in the urine, in the blood, in the appendages (hair).

    Measured: up 12 months after surgical intervention

  28. Concentrations of iron constituting the Essure® implant

    Concentrations of iron constituting the Essure® implant in the peritoneal fluid, in the surgical piece, in the urine, in the blood, in the appendages (hair).

    Measured: up 12 months after surgical intervention

  29. concentration of pro-inflammatory cytokines

    concentration of pro-inflammatory cytokines in the blood will be assessed

    Measured: Up 2 months after surgical intervention

  30. expression profile of miRNAs

    Expression profile of miRNAs in the peritoneal fluid will be assessed.

    Measured: Up 2 months after surgical intervention

  31. activated T lymphocyte profile

    activated T lymphocyte profile in blood will be assessed.

    Measured: Up 2 months after surgical intervention

  32. analysis of inflammatory pathway mRNAs

    analysis of inflammatory pathway mRNAs (nanostring® technology) in a pathology sample from the surgical specimen will be assessed.

    Measured: Up 2 months after surgical intervention

  33. Percentage of detection of Human Leukocyte Antigen

    Percentage of detection of Human Leukocyte Antigen (HLA)-DR53 (DRB4∗01) associated with nickel allergies in blood will be assessed.

    Measured: Up 2 months after surgical intervention

  34. Functional brain functions

    MRI-PET (Magnetic resonance imaging- Positron Emission Tomography) examination :

    • Mapping of brain inflammation: binding potential mapping of [11C]PK11195 characteristic of activated microglia
    • Brain anatomical imaging: clinical type anatomical MRI examination to assess the presence of cerebral anatomical abnormality
    • Brain mapping of functional connectivity at rest using Functional magnetic resonance imaging (fMRI)
    • Brain mapping of structural connectivity by diffusion MRI
    • Perfusion imaging : perfusion MRI examination without contrast product to assess the presence of cerebral perfusion abnormality
    • Magnetic susceptibility imaging: to detect possible hemorrhages

    Measured: up 6 months after Surgical intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2024
  2. Study start17 Feb 2025
  3. Primary completion17 Apr 2032 (estimated)
  4. Study completion17 Feb 2037 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
444 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06355713
Sponsor's protocol ID
69HCL23_0899
Other IDs
2023-A02010-45
Acronym
ABLES
Status last verified
Mar 2026
First submitted
28 Mar 2024
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Magnetic resonance imaging- Positron Emission Tomography (MRI-PET) examination, blood sample and urine collection in people with Implant Complication and Contraceptive Device; Complications, run by Hospices Civils de Lyon at 10 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gautier Chene, PU,PH (0472355870 ext. +33, gautier.chene@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients with improvement in symptoms Percentage of patients with improvement in symptoms (time frame: At 2 months after surgical intervention (removal of the Essure® contraceptive implant)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06355713.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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