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Recruiting NCT07175857

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

Trial Parameters

Condition Endometriosis
Sponsor Lyv Healthcare
Study Type INTERVENTIONAL
Phase N/A
Enrollment 304
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2025-07-21
Completion 2026-08-31
Interventions
Lyv Endo app

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.

Eligibility 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

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