Evaluation of the Efficacy of an Innovative Digital Therapeutic Medical Device, Lyv Endo, for the Management of Patients With Endometriosis
NCT ID: NCT07175857
Last Updated: 2025-09-16
Study Results
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Basic Information
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RECRUITING
NA
304 participants
INTERVENTIONAL
2025-07-21
2026-08-31
Brief Summary
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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.
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Detailed Description
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Endometriosis is characterized by the presence of endometrium-like tissue outside the uterus, which may lead to severe pain, particularly during menstruation, as well as infertility in approximately one-third of cases. On average, diagnosis is delayed by seven years, complicating the management of the disease. Common symptoms include severe menstrual pain (dysmenorrhea), chronic pelvic pain, deep dyspareunia, dyschezia during menstruation, cyclic urinary symptoms, and infertility.
Diagnosis is primarily clinical, supported by imaging examinations such as transvaginal ultrasound and pelvic MRI to confirm the presence of lesions. In the absence of conclusive findings, empirical treatment may be initiated based on symptom relief, with a presumptive diagnosis. Laparoscopy, previously a routine diagnostic procedure, is now reserved for complex cases where imaging is inconclusive and treatments have failed.
To date, there is no curative treatment for endometriosis. Current treatments are symptomatic and include hormonal therapies (progestins or combined oral contraceptives), hormonal intrauterine devices, and analgesics (e.g., tramadol, nefopam, paracetamol-codeine or paracetamol-tramadol combinations). Up to 83% of patients continue to experience persistent symptoms despite medical or surgical treatment. In cases of severe pain or infertility resistant to treatment, surgical intervention may be considered, although recurrence is possible.
Given the chronic nature of the symptoms, endometriosis is a complex, multifactorial disease requiring multidisciplinary care. An integrative approach-including therapeutic education, regular physical activity, psychological support, and dietary measures-is essential to improve symptom management and patient quality of life. Supportive therapies such as physiotherapy and sophrology have shown benefits in endometriosis patients. These non-pharmacological therapies are increasingly recommended by pain specialists to address central sensitization and help raise pain thresholds, which are pathologically low in patients with chronic pelvic pain. This multimodal and multidisciplinary approach, as a complement to conventional pharmacological treatment, aligns with the HAS recommendations for managing chronic pain, which apply to endometriosis patients.
However, most patients still lack access to such multidisciplinary care. This gap may be partly due to insufficient training in endometriosis among frontline healthcare professionals (e.g., general practitioners and community gynecologists), who are often unaware of the proven benefits of this type of approach and do not refer patients to relevant professionals (e.g., physiotherapists, psychologists, sex therapists). Additionally, the number of healthcare professionals specialized in endometriosis remains limited, especially in medically underserved areas. Finally, due to limited consultation time, healthcare providers may not be able to address all these aspects during routine visits.
Over the past decade, the development of digital technologies and connected devices has opened new perspectives in patient care. These tools can play a crucial role by offering innovative solutions to relieve pain, enhance patient education, and foster greater autonomy in symptom self-management. In the field of endometriosis, there are currently very few digital medical devices specifically dedicated to supporting patients.
The Lyv Endo device is a CE-marked Class I digital therapeutic medical device that stands out through its integrative, patient-centered approach to endometriosis management. Its innovation lies in its ability to deliver comprehensive and personalized content tailored to each patient's symptoms, addressing key limitations of traditional care (e.g., limited consultation time, low availability of trained professionals). This digital medical device offers individualized therapeutic support across five key modules: disease knowledge, mental well-being, adapted physical activity, nutrition, and sexual health. Lyv Endo is positioned at the forefront of digital medical technologies, with the goal of transforming endometriosis care.
The main objective is to evaluate the clinical impact of using an innovative digital therapeutic device on the quality of life of patients with endometriosis.
Secondary Objectives :
* To evaluate the clinical impact of using the Lyv Endo digital therapeutic on the quality of life of patients with endometriosis
* To evaluate the clinical impact on symptoms and complications associated with endometriosis
* To evaluate the clinical impact on mental health
* To assess the impact on lifestyle habits
* To assess the organizational impact
* To assess the health economic impact
* To evaluate the usability of the full version of the therapeutic digital medical device
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Control
standard care
No interventions assigned to this group
Intervention
Use of the Lyv Endo app + standard care
Lyv 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.
Interventions
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Lyv 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Lyv Healthcare
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Facility Contacts
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References
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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.
Aubry 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.
O'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.
Coxon 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.
Cohen 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.
Zondervan KT, Becker CM, Missmer SA. Endometriosis. N Engl J Med. 2020 Mar 26;382(13):1244-1256. doi: 10.1056/NEJMra1810764. No abstract available.
Related Links
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Description of the Lyv Endo app in french
Other Identifiers
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LYVENDO
Identifier Type: -
Identifier Source: org_study_id
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