NCT07184528 PATCHVALVE: Endobronchial Valves Plus Blood Patch for Persistent Air Leaks
| NCT ID | NCT07184528 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beth Israel Deaconess Medical Center |
| Condition | Persistent Air Leaks |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-07-01 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
{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
Contact & Investigator
Jason Beattie, MD
PRINCIPAL INVESTIGATOR
Beth Israel Deaconess Medical Center
Frequently Asked Questions
Who can join the NCT07184528 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Persistent Air Leaks. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07184528 currently recruiting?
Yes, NCT07184528 is actively recruiting participants. Contact the research team at jbeattie@bidmc.harvard.edu for enrollment information.
Where is the NCT07184528 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT07184528 clinical trial?
NCT07184528 is sponsored by Beth Israel Deaconess Medical Center. The principal investigator is Jason Beattie, MD at Beth Israel Deaconess Medical Center. The trial plans to enroll 20 participants.