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Could a tiny zap ease endometriosis agony? new trial aims to find out.

NCT ID NCT07317037

Symptom relief Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a portable device called ActiTENS mini that uses mild electrical pulses to relieve chronic pelvic pain in women with endometriosis. About 208 women will try different stimulation strengths over 9 months to see if it reduces pain and improves quality of life. If it works, doctors may prescribe it as a drug-free option.

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 208 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

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

18 years and older

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: * Women over 18 years old * Followed-up in gynecology consultation for endometriosis confirmed by specific imaging (MRI or ultrasound) * Referred to a gynecological or a pain center * With chronic pelvic pain (for at least 3 months) related to endometriosis, pelvic pain being the predominant symptom of endometriosis: pelvic pain present at least 15 days per month in the previous 3 months * Stable and optimal analgesic and hormonal treatments during the last 3 months: any modification of pharmacological treatment in the last 3 months * Pelvic pain of moderate to severe intensity or greater than or equal to 4 on an NRS of 0-10 on average during the 8 days preceding the inclusion visit and during the inclusion visit. * Informed about the concept and accepting the use of TENS as a device, a non-drug analgesic treatment. * Able to understand the use of TENS * Having a personal smartphone enabling the EndoTENS application to be downloaded * All women of childbearing potential (WOCBP) must agree to maintain highly effective contraception by practicing abstinence or by using an effective method of birth control from the date of consent through the end of the study: Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (Oral, Intravaginal, Transdermal); Progestogen-only hormonal contraception associated with inhibition of ovulation (Oral, Injectable, Implantable); Intrauterine device (IUD); Intrauterine hormone-releasing system (IUS); Bilateral tubal occlusion; Vasectomized partner, spermicide-coated condoms * Willingness and ability to attend the scheduled study visits and comply with study procedures * Affiliated to Social Security. Exclusion Criteria: * Symptoms of endometriosis other than pelvic pain, predominant over pelvic pain (pelvic pain is not the main symptom): digestive disorders, unstable bladder, dyspareunia, infertility, fibromyalgia, sciatica, low back pain… * Present or past allergy to actiTENS mini pads. * Pelvic surgery planned within the next 11 months. * Drug or non-pharmacological treatments not stabilized, which could influence the pathology studied during the last 3 months * Changed of treatments for endometriosis planned in the next 10 months. * Patient presenting an absolute contraindication to TENS: patient with epilepsy, patient with a defibrillator, a pacemaker, a cochlear implant or other implanted electronic devices, patient with cardiac disorders, patient with decreased or altered sensation or sensitivity in the area to be treated, for example patients with allodynia (pain triggered by a stimulus that is normally painless) in the area to be treated. * Patient unable to express his consent or patient in deprivation of liberty. * Patient that already used or know the functioning principles of a TENS device previously to the clinical study * Contraindications to actiTENS mini * Pregnancy and breastfeeding * Patients under guardianship or curatorship and protected adults * Patients on AME (Aide Médicale de l'Etat = State Medical Assistance) * Current participation in another research study involving a therapeutic intervention. Participation to an observational research, or a non-interventional research is allowed

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Conditions

The condition(s) this trial relates to.

endometriosis Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Endometriosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    27 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

  • APHP - Bichat

    Paris, 75018, France

  • APHP - COCHIN - gynécologie

    Paris, 75014, France

  • APHP - COCHIN -centre douleur

    Paris, 75014, France

  • Aphm - Hopital Nord

    Marseille, 13005, France

  • Aphm - Hopital de La Conception

    Marseille, 13005, France

  • Aphp - Antoine Beclere

    Clamart, 92140, France

  • Aphp - Hegp

    Paris, 75015, France

  • Aphp - Kremlin Bicetre

    Le Kremlin-Bicêtre, 94275, France

  • Aphp - Louis Mourier

    Colombes, 92700, France

  • Aphp - Pitie Salpetriere

    Paris, 75013, France

  • Ch Rene Dubos - Hopital Novo

    Pontoise, 95300, France

  • Chi de Creteil

    Créteil, 94000, France

  • Chru Nancy - Maternite

    Nancy, 54042, France

  • Chru Rennes Site Hopital Sud

    Rennes, 35200, France

  • Chu Amiens Sud

    Amiens, 80000, France

  • Chu Cote de Nacre - Caen

    Caen, 14033, France

  • Chu La Miletrie

    Poitiers, 86021, France

  • Chu de Nantes Site Hotel Dieu Hme

    Nantes, 44093, France

  • Chu de Saint-Etienne

    Saint-Etienne, 42055, France

  • Clinique Tivoli-Ducos

    Bordeaux, 33000, France

  • GH PARIS SITE SAINT JOSEPH - douleur chronique

    Paris, 75014, France

  • Gh Paris Site Saint Joseph

    Paris, 75014, France

  • Grenoble

    Grenoble, 38700, France

  • Hop Jeanne de Flandre Chu Lille

    Lille, 59000, France

  • Hopital Croix-Rousse - Hcl

    Lyon, 69317, France

  • Hopital Lyon Sud - Hcl

    Lyon, 69495, France

  • Hopital Maison Blanche Chu Reims

    Reims, 51092, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.