Health TrialsbyHealthPanel

Improvement of Symptoms After Removal of the Essure® Contraceptive Implant

ConditionsImplant ComplicationContraceptive Device; Complications
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age35-75
SponsorHospices Civils de Lyon

About this trial

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 Marketed in 2002, ESSURE® contraceptive implants were withdrawn from the French market in 2017 (and worldwide in 2017 and 2018) following the observation in certain patients of polymorphic and non-specific gynecological and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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Device

    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 sample

    Biological/Vaccine

    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 collection

    Biological/Vaccine

    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 hair

    Biological/Vaccine

    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

  • questionnaire

    Other intervention

    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

Treatment groups

444 Participants
are divided into 2 treatment groups
Group A: Essure GroupExperimental treatment 5 interventions
Group B: Control GroupActive comparator 5 interventions

Trial outcomes

Primary outcomes

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.

Time frame
At 2 months after surgical intervention (removal of the Essure® contraceptive implant)

Secondary outcomes

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.

Time frame
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.

Time frame
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)

Time frame
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)

Time frame
up 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospices Civils de Lyon

Lead sponsor

Source ClinicalTrials.gov
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