Evaluation of the Efficacy of an Innovative Digital Therapeutic Medical Device, Lyv Endo, for the Management of Patients With Endometriosis
LYVENDO
1 other identifier
interventional
410
1 country
8
Brief Summary
The main objective of this clinical study is to evaluate the clinical impact of using an innovative digital therapeutic device on the quality of life of patients with endometriosis. The working hypothesis is that the therapeutic digital medical device Lyv Endo may improve quality of life and reduce symptom intensity by enhancing patient engagement in the management of their condition. This justifies the need to evaluate the effect of Lyv Endo as a complement to standard medical care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2025
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 21, 2025
CompletedFirst Submitted
Initial submission to the registry
August 7, 2025
CompletedFirst Posted
Study publicly available on registry
September 16, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
May 7, 2026
May 1, 2026
1.1 years
August 7, 2025
May 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical impact
Change in Endometriosis Health Profile-5 score ranging from 0 (best outcome) to 100 (worst outcome)
Baseline and 3 months
Secondary Outcomes (20)
Clinical Impact
Baseline and 3 months
Clinical Impact
3 months
Clinical Impact
Baseline and 3 months
Clinical Impact
Baseline and 3 months
Clinical Impact
Baseline and 3 months
- +15 more secondary outcomes
Study Arms (2)
Control
NO INTERVENTIONstandard care
Intervention
EXPERIMENTALUse of the Lyv Endo app + standard care
Interventions
Lyv Endo is a CE-marked Class I therapeutic digital medical device offering a patient-centered, integrative approach. Its innovation lies in its ability to deliver personalized content based on symptoms, surpassing the limits of traditional care.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lyv Healthcarelead
Study Sites (8)
Hôpital Privé de Provence
Aix-en-Provence, France, 13080, France
CHU CAEN
Caen, France, 14000, France
CHU Rennes
Rennes, France, 35000, France
Clinique Tivoli Ducos
Bordeaux, 33000, France
Centre Hospitalier de Versailles
Le Chesnay, 78157, France
Centre Hospitalier Le Mans
Le Mans, 72000, France
Hôpital Le Blois
Lille, 59000, France
Hôpital Paris Saint-Joseph
Paris, 75014, France
Related Publications (6)
Breton Z, Stern E, Pinault M, Lhuillery D, Petit E, Panel P, Alexaline M. A Digital Program for Daily Life Management With Endometriosis: Pilot Cohort Study on Symptoms and Quality of Life Among Participants. JMIR Form Res. 2025 Feb 28;9:e58262. doi: 10.2196/58262.
PMID: 39791286BACKGROUNDAubry G, Panel P, Thiollier G, Huchon C, Fauconnier A. Measuring health-related quality of life in women with endometriosis: comparing the clinimetric properties of the Endometriosis Health Profile-5 (EHP-5) and the EuroQol-5D (EQ-5D). Hum Reprod. 2017 Jun 1;32(6):1258-1269. doi: 10.1093/humrep/dex057.
PMID: 28383700BACKGROUNDO'Hara R, Rowe H, Fisher J. Managing endometriosis: a cross-sectional survey of women in Australia. J Psychosom Obstet Gynaecol. 2022 Sep;43(3):265-272. doi: 10.1080/0167482X.2020.1825374. Epub 2020 Oct 13.
PMID: 33050751BACKGROUNDCoxon L, Vollert J, Perro D, Lunde CE, Ferreira-Gomes J, Charrua A, Abreu-Mendes P, Krassowski M, Birch J, Meijlink J, Hummelshoj L, Hoffmann A, Aziz Q, Arendt-Nielsen L, Pogatzki-Zahn E, Evans E, Demetriou L, McMahon SB, Missmer SA, Becker CM, Zondervan KT, Horne AW, Cruz F, Sieberg CB, Treede RD, Nagel J, Vincent K. Comprehensive quantitative sensory testing shows altered sensory function in women with chronic pelvic pain: results from the Translational Research in Pelvic Pain (TRiPP) Study. Pain. 2023 Nov 1;164(11):2528-2539. doi: 10.1097/j.pain.0000000000002955. Epub 2023 Jun 7.
PMID: 37289573BACKGROUNDCohen SP, Vase L, Hooten WM. Chronic pain: an update on burden, best practices, and new advances. Lancet. 2021 May 29;397(10289):2082-2097. doi: 10.1016/S0140-6736(21)00393-7.
PMID: 34062143BACKGROUNDZondervan KT, Becker CM, Missmer SA. Endometriosis. N Engl J Med. 2020 Mar 26;382(13):1244-1256. doi: 10.1056/NEJMra1810764. No abstract available.
PMID: 32212520BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2025
First Posted
September 16, 2025
Study Start
July 21, 2025
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 31, 2026
Last Updated
May 7, 2026
Record last verified: 2026-05