Lyv Endo: a digital therapeutic app to help manage endometriosis
Evaluation of the Efficacy of an Innovative Digital Therapeutic Medical Device, Lyv Endo, for the Management of Patients With Endometriosis
This project will test whether the Lyv Endo app can help adults with confirmed endometriosis in France have better quality of life and reduced symptom severity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 410 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Lyv Healthcare Industry-sponsored |
| Locations | 8 sites (Aix-en-Provence, France and 7 other locations) |
| Trial ID | NCT07175857 on ClinicalTrials.gov |
What this trial studies
Adults with confirmed, symptomatic endometriosis who meet inclusion criteria will use the Lyv Endo digital therapeutic app alongside their usual medical care. Investigators will collect baseline and follow-up measures of quality of life and symptom intensity to track changes over the study period. Key exclusions include recent or planned surgery, current fertility hormone treatment, pregnancy or breastfeeding, prior full use of Lyv Endo, and cognitive or legal incapacity to consent. The primary focus is on whether adding the app to standard care improves patient-reported outcomes.
Who should consider this trial
Good fit: Adults aged 18 or older in France with a confirmed diagnosis of endometriosis, at least moderate symptoms (NRS ≥ 4), who are French-speaking, own a smartphone with internet access, and are covered by French social security.
Not a fit: Patients who are pregnant or breastfeeding, planning or recently having had surgery, receiving fertility hormone treatments, previously exposed to the full Lyv Endo program, or with cognitive/psychiatric conditions that impair consent are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, Lyv Endo could offer a non-invasive, accessible way to improve quality of life and reduce pain and other symptoms for people with endometriosis.
How similar studies have performed: Some small trials of digital self-management and therapeutic apps for chronic pelvic pain and endometriosis-related symptoms have shown modest benefits, but the Lyv Endo device itself is a novel, device-specific intervention without large-scale proof yet.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women ≥18 years old * with confirmed endometriosis diagnosis * symptomatic patients (NRS ≥ 4 on one or more symptoms) * French-speaking * Owning a smartphone with internet/data, * covered by French social security Exclusion Criteria: * Planned surgery during the study or surgery in the past 8 weeks * Fertility hormone treatment during study * Previous use of full Lyv Endo app or pilot program * Pregnant or breastfeeding * Under legal protection (guardianship, etc.) * Cognitive or psychiatric conditions compromising consent * Judged non-autonomous by investigator * Participation in another interventional study
Where this trial is running
Aix-en-Provence, France and 7 other locations
- Hôpital Privé de Provence — Aix-en-Provence, France, France (Recruiting)
- Chu Caen — Caen, France, France (Recruiting)
- CHU Rennes — Rennes, France, France (Recruiting)
- Clinique Tivoli Ducos — Bordeaux, France (Recruiting)
- Centre Hospitalier de Versailles — Le Chesnay, France (Recruiting)
- Centre Hospitalier Le Mans — Le Mans, France (Recruiting)
- Hôpital Le Blois — Lille, France (Recruiting)
- Hôpital Paris Saint-Joseph — Paris, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.