NeurostimulationTENSESNCT07900971
Transcutaneous Electrical Neurostimulation After Ablation of Essure®
An observational study of Neurostimulation and TENS, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The ESSURE® device 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 18 years and older, women only
- Conditions the study is for
- Neurostimulation, TENS, Vagus Nerve
- What is being tested?
- Improvement in patients' symptoms
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2025to 1 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: This study covers all patients who received treatment with the TENS ECO PLUS device for persistent symptoms after removal of the Essure® implant.
Who may be able to join
- women over 18
- patients who received treatment with the TENS ECO PLUS device for persistent symptoms after removal of the Essure® implant
- treatment between February 2025 and September 2025
- person having expressed his non-opposition
Who cannot join
- inability to understand the information given
- person deprived of liberty
- person under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evolution of Symptoms Resistant to Removal of the Essure® Implant After Use of Transcutaneous Electrical Neurostimulation
The ESSURE® device 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 Marketed in 2002, ESSURE® contraceptive implants were withdrawn from the French market in 2017 (and worldwide in 2017 and 2018) following the observation in certain patients of polymorphic and non-specific gynecological and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. The hypothesis would be a dissemination of the metallic elements contained in these implants.
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 Scientific Interest Group EPI-PHARE, 198,000 French women have these implants and only 30,000 of them, or 15%, have been explanted. A large number of these patients, presenting symptoms, have not yet been treated for an explant.
Although explantation of these implants is now recommended in symptomatic patients, approximately 20 to 30% of these patients remain symptomatic after explantation in the form of fibromyalgia signs. Transcutaneous electrical neurostimulation of the vagus nerve uses a non-invasive portable device that is positioned at ear level for 20 minutes per day and allows painless stimulation of the vagus nerve. This device is indicated in fibromyalgia as a non-drug and non-invasive device. This device (TENS ECO PLUS) is offered in routine practice in the service to still symptomatic patients with fibromyalgia symptoms after explantation of the Essure device. In this study, we wish to evaluate the improvement of the symptoms of these patients.
- Being tested
- Improvement in patients' symptoms
- Keywords
- Essure®, neurostimulation, TENS, vagus nerve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improvement in patients' symptomsOther
Improvement in patients' symptoms on the PGI-I scale (score 1, 2 or 3) at 3 months after the start of treatment
| Study group | Role | What they receive |
|---|---|---|
| TENS | patients who received treatment with the TENS ECO PLUS device for persistent symptoms after removal of the Essure® implant. Receives: Other: Improvement in patients' symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in patients' symptoms
Improvement in patients' symptoms on the PGI-I scale (score 1, 2 or 3) at 3 months after the start of treatment
Measured: 3 months after the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start1 Dec 2025
- Primary completion1 Feb 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurostimulationStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900971
- Sponsor's protocol ID
- 25-5460
- Acronym
- TENSES
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Symptoms Resistant to Removal of the Essure® Implant After Use of Transcutaneous Electrical Neurostimulation
- ClinicalTrials.gov ID
- NCT07900971
- Acronym / sponsor ID
- TENSES / 25-5460
- Keywords
- Essure®, neurostimulation, TENS, vagus nerve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ESSURE® device 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. The hypothesis would be a dissemination of the metallic elements contained in these implants.
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 Scientific Interest Group EPI-PHARE, 198,000 French women have these implants and only 30,000 of them, or 15%, have been explanted. A large number of these patients, presenting symptoms, have not yet been treated for an explant.
Although explantation of these implants is now recommended in symptomatic patients, approximately 20 to 30% of these patients remain symptomatic after explantation in the form of fibromyalgia signs. Transcutaneous electrical neurostimulation of the vagus nerve uses a non-invasive portable device that is positioned at ear level for 20 minutes per day and allows painless stimulation of the vagus nerve. This device is indicated in fibromyalgia as a non-drug and non-invasive device. This device (TENS ECO PLUS) is offered in routine practice in the service to still symptomatic patients with fibromyalgia symptoms after explantation of the Essure device. In this study, we wish to evaluate the improvement of the symptoms of these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TENS | – | Other: Improvement in patients' symptomspatients who received treatment with the TENS ECO PLUS device for persistent symptoms after removal of the Essure® implant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study covers all patients who received treatment with the TENS ECO PLUS device for persistent symptoms after removal of the Essure® implant.
Key inclusion criteria (4 listed)
Key exclusion criteria (3 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Improvement in patients' symptomsImprovement in patients' symptoms on the PGI-I scale (score 1, 2 or 3) at 3 months after the start of treatment | Other | TENS |
Primary outcome
Improvement in patients' symptoms
Time frame: 3 months after the start of treatment
Improvement in patients' symptoms on the PGI-I scale (score 1, 2 or 3) at 3 months after the start of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurostimulation and TENS, run by Hospices Civils de Lyon at 1 site 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in patients' symptoms (time frame: 3 months after the start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2026.