Home › NCT07184528

PATCHVALVE: Endobronchial Valves Plus Blood Patch for Persistent Air Leaks

PATCHVALVE Trial: A Prospective Evaluation of Blood Patch and Endobronchial Valves for Persistent Air Leaks - Pilot Study

Who can join

Ages 18 and older · All sexes

{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

About the study

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.

What is being tested

• Endobronchial Blood Patch (device)
• Spiration Valve System (SVS) Placement (device)

Sponsor: Beth Israel Deaconess Medical Center · Participants: 20 · Started: Jul 1, 2025

Contact the study team

• Jason Beattie, MD · Phone: 3105298266

Official record on ClinicalTrials.gov — NCT07184528

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.