RecruitingNot ApplicableNCT07175857

Evaluation of the Efficacy of an Innovative Digital Therapeutic Medical Device, Lyv Endo, for the Management of Patients With Endometriosis


Sponsor

Lyv Healthcare

Enrollment

304 participants

Start Date

Jul 21, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria6

  • 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 Criteria8

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICELyv Endo app

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.


Locations(6)

Clinique Tivoli Ducos

Bordeaux, France

Centre Hospitalier de Versailles

Le Chesnay, France

Centre Hospitalier Le Mans

Le Mans, France

Hôpital Le Blois

Lille, France

Hôpital Paris Saint-Joseph

Paris, France

Centre Hospitalier de Saint Nazaire

Saint-Nazaire, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07175857


Related Trials