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NCT07184528 · ClinicalTrials.gov registry record · NA
PATCHVALVE: Endobronchial Valves Plus Blood Patch for Persistent Air Leaks
A NA study of Persistent Air Leaks, sponsored by Beth Israel Deaconess Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT07184528: Recruiting NA study of Persistent Air Leaks, sponsored by Beth Israel Deaconess Medical Center.
NCT07184528 is a NA study of Persistent Air Leaks that is actively recruiting participants, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07184528, a NA study of Persistent Air Leaks, is actively recruiting participants, sponsored by Beth Israel Deaconess Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
This outcome will assess the safety of the combined blood patch and Spiration valve intervention by measuring the number of participants who experience one or more adverse events. Adverse events may include valve migration, the emergence of new air leaks in lung lobes other than the treated segment, and deterioration in pulmonary function, such as worsened gas exchange or progression to respiratory failure. Units: Binary (YES/NO)
Conditions Studied
Interventions
- DEVICE Endobronchial Blood Patch
- DEVICE Spiration Valve System (SVS) Placement
Study Locations (1)
Massachusetts
- Beth Isreal Deaconess Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-07-01 |
| Est. Completion | 2027-07-01 |
| Phase | NA |
What NCT07184528 shows while recruiting
NCT07184528 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Persistent Air Leaks appearing as the primary indexed condition, and to 2 interventions - of which Endobronchial Blood Patch is the first listed.
NCT07184528 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT07184528 about?
NCT07184528 is a clinical study titled "PATCHVALVE: Endobronchial Valves Plus Blood Patch for Persistent Air Leaks". 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 as...
What is the current status of trial NCT07184528?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2025-07-01. Estimated completion is 2027-07-01.
What conditions does trial NCT07184528 study?
This clinical trial studies the following conditions: Persistent Air Leaks.
What interventions are being tested in trial NCT07184528?
The interventions under investigation include: Endobronchial Blood Patch (DEVICE), Spiration Valve System (SVS) Placement (DEVICE).
Who is sponsoring clinical trial NCT07184528?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07184528 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07184528's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 of 2,000 other NA trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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