Status:
NOT_YET_RECRUITING
Real Life Evaluation of the LibAirty Airway Clearance System in Adults With Bronchiectasis (RELACS)
Lead Sponsor:
Synchrony-Medical, Ltd
Conditions:
Bronchiectasis Adult
Eligibility:
All Genders
21+ years
Brief Summary
The purpose of this study is to collect data to assess the use of the LibAirty™ System for improving bronchiectasis symptoms and healthcare resource utilization when it is used at home. The main ques...
Detailed Description
This prospective, single-arm, open-label study aims to evaluate the real-world use of the LibAirty™ Airway Clearance System for airway clearance in adult patients with bronchiectasis in a home setting...
Eligibility Criteria
Inclusion
- Have a radiological diagnosis of Bronchiectasis based on high resolution chest CT scan
- Have bronchiectasis characterized by either:
- Daily productive cough (as determined by a treating physician)
- OR Available documentation from the last 12 months of 2 or more pulmonary exacerbations requiring antibiotic therapy
- Be at age ≥ 21 years
- Prescribed and receives the LibAirty system for home use
- Be on a standard of care treatment plan that includes at least one physician encounter every 6 months
- No change in treatment for Bronchiectasis in the 2-month period prior to enrollment
- Signed informed consent
Exclusion
- Inability to independently perform therapy with the LibAirty system as directed
- Any other condition that, in the opinion of the PI, could jeopardize the safety of the subject or impact the validity of the study results.
- Pregnancy or planned pregnancy during the expected duration of the trial (12 months).
Key Trial Info
Start Date :
August 31 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07135284
Start Date
August 31 2025
End Date
February 1 2027
Last Update
August 22 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.