NCT06523140 Management of COPD Patients With BoraCare® Remote Monitoring Solution Including BVS3 Early Detection Score for COPD Exacerbations
| NCT ID | NCT06523140 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Biosency |
| Condition | COPD |
| Study Type | INTERVENTIONAL |
| Enrollment | 380 participants |
| Start Date | 2024-11-20 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 380 participants in total. It began in 2024-11-20 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to demonstrate the superiority of remote monitoring with the Bora Care solution in patients with COPD and frequent exacerbations (experimental group) compared to conventional follow-up alone (control group) on the total number of hospital days per patient for respiratory deterioration over 12 months of follow-up. The main question it aims to answer is: Does remote monitoring of COPD patients reduce the average annual length of hospitalization for exacerbations of COPD patients? All participants will benefit a conventional clinical follow-up. Participants in experimental group will also benefit from the Bora care remote monitoring system.
Eligibility Criteria
Inclusion Criteria: * Patient over 18 years of age with COPD defined according to the recommendations of the SPLF, whose level of respiratory function in a stable state is known (measured less than 12 months), recruited in pulmonology * Patient who has been hospitalized for COPD exacerbation in the previous 12 months * Informed patient who has signed consent, * Patient enrolled in a social security scheme (Art L1121-11 of the CSP) Exclusion Criteria: * Presence of a comorbidity considered unstable or very severe by the investigator. * Patient with psychological frailties, * Patient already included in another interventional trial, * Patient who does not speak French and is unable to use the Bora Band tool and without access to a caregiver, * Patient protected under guardianship or unable to give free and informed consent. * Pregnant or nursing woman
Contact & Investigator
Nicolas ROCHE, MD
PRINCIPAL INVESTIGATOR
Hôpital Cochin, AP-HP
Frequently Asked Questions
Who can join the NCT06523140 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying COPD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06523140 currently recruiting?
Yes, NCT06523140 is actively recruiting participants. Contact the research team at clinical@biosency.com for enrollment information.
Where is the NCT06523140 trial being conducted?
This trial is being conducted at Brest, France, Vannes, France, Le Coudray, France, Verdun, France and 6 additional locations.
Who is sponsoring the NCT06523140 clinical trial?
NCT06523140 is sponsored by Biosency. The principal investigator is Nicolas ROCHE, MD at Hôpital Cochin, AP-HP. The trial plans to enroll 380 participants.
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