Clinical Trial

PATCHVALVE: Endobronchial Valves Plus Blood Patch for Persistent Air Leaks

Recruiting
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Record status
This record was last updated September 22, 2025 (before its estimated July 1, 2026 completion). Its status may not reflect the trial's current state.
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 air leaks (PALs) in adult patients undergoing bronchoscopy. PALs are a challenging condition often associated with prolonged hospital stays, increased morbidity, and delayed recovery. The main questions this study aims to answer are: * Does the combination of endobronchial valve placement and endobronchial blood patching accelerate resolution of persistent air leaks? * What are the procedural outcomes, complications, and hospital-related metrics (e.g., chest tube duration, length of stay, and readmission rates) associated with this technique? Participants will: * Undergo standard-of-care bronchoscopy with identification of air leak source. * Receive intrabronchial instillation of autologous blood and tranexamic acid (TXA) followed by balloon occlusion and endobronchial valve placement. * Be followed for resolution of air leak and post-procedure outcomes through standard inpatient monitoring and data collection.
Trial Details
NCT Number NCT07184528
Lead Sponsor Beth Israel Deaconess Medical Center
Conditions Persistent Air Leaks
Enrollment 20 participants
Start Date 2025-07-01
Primary Completion 2026-07-01 (estimated)
Study Completion 2027-07-01 (estimated)
Updated on ClinicalTrials.gov 2025-09-22