Status:
RECRUITING
PATCHVALVE: Endobronchial Valves Plus Blood Patch for Persistent Air Leaks
Lead Sponsor:
Beth Israel Deaconess Medical Center
Conditions:
Persistent Air Leaks
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this study is to evaluate the real-world safety and effectiveness of combining endobronchial valve (IBV) placement with endobronchial blood patching (EBP) for the treatment of persistent a...
Detailed Description
This study will include a prospective cohort of adult patients with persistent air leaks (PALs) undergoing bronchoscopy. The intervention evaluated is a combination approach that includes endobronchia...
Eligibility Criteria
Inclusion
- {Inclusion Criteria}
- Adult (≥18 years) patients who have been diagnosed with persistent air leaks (PALs) due to conditions such as alveolar-pleural fistulas following pulmonary resections, traumatic injury, or underlying lung disease or other cause.
- PAL patients who are deemed non-candidates for surgical intervention or have declined surgery.
- {Exclusion Criteria}
- Patients who have received other experimental or investigational treatments for PALs that could confound the results.
- Patients with contraindications to undergoing bronchoscopy, such as severe cardiovascular instability, or those who cannot tolerate the procedure due to other medical reasons.
- Bronchopleural fistula
Exclusion
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07184528
Start Date
July 1 2025
End Date
July 1 2027
Last Update
September 22 2025
Active Locations (1)
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1
Beth Isreal Deaconess Medical Center
Boston, Massachusetts, United States, 02215