Endobronchial valves with an airway blood patch for persistent air leaks
Official title: PATCHVALVE Trial: A Prospective Evaluation of Blood Patch and Endobronchial Valves for Persistent Air Leaks - Pilot Study
Run by Beth Israel Deaconess Medical Center · NCT07184528 · Data updated 2026-11-12
This study will try combining an airway blood patch with endobronchial valves to stop persistent air leaks in adults who cannot or do not want surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | July 1, 2025 |
| Main results expected | July 1, 2026 |
| Study ends | July 1, 2027 |
| Registry record updated | September 22, 2025 |
| Trial ID | NCT07184528 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with persistent air leaks who are not candidates for surgery or who decline surgery and who can safely undergo bronchoscopy are the ideal candidates.
✕Probably not a fit
Patients with bronchopleural fistula, those with contraindications to bronchoscopy or severe cardiovascular instability, or those who have received other investigational PAL treatments may not receive benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective cohort enrolls adult patients with persistent air leaks who undergo bronchoscopy to locate the leak. The procedure pairs instillation of autologous blood (up to 30 mL) plus tranexamic acid (up to 10 mL) into the leaking airway, balloon occlusion for 3–5 minutes, and deployment of endobronchial valves as indicated. Investigators will track time to leak resolution, chest tube duration, length of stay, procedural complications, and readmissions. Consenting prospective participants will receive standard imaging and evaluations to guide treatment decisions.
Why it matters
Potential benefit: If successful, the combined technique could reduce chest tube time, shorten hospital stays, and lower the need for surgery in patients with persistent air leaks.
How similar studies have gone: Endobronchial valves and autologous blood patches have each shown promise for managing persistent air leaks, but their combined use is relatively new with limited published data.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Beth Isreal Deaconess Medical Center
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Jason Beattie, MD — Beth Israel Deaconess Medical Center
- Study coordinator: Jason Beattie, MD
- Email: jbeattie@bidmc.harvard.edu
- Phone: 3105298266
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.