Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07184528

PATCHVALVE: Endobronchial Valves Plus Blood Patch for Persistent Air Leaks

Led by Beth Israel Deaconess Medical Center · Updated on 2025-09-22

20

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

PATCHVALVE: Endobronchial Valves Plus Blood Patch for Persistent Air Leaks

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 years or older with persistent air leaks (PALs) from causes such as alveolar-pleural fistulas after lung surgery, trauma, lung disease, or other reasons
  • Patients with PALs who are not candidates for surgery or have declined surgery
Not Eligible

You will not qualify if you...

  • Patients who have had other experimental or investigational treatments for persistent air leaks that might affect study results
  • Patients who cannot safely undergo bronchoscopy due to severe cardiovascular instability or other medical reasons
  • Patients with bronchopleural fistula

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Beth Isreal Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

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Research Team

J

Jason Beattie, MD

CONTACT

C

Christine Conley, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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