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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will include a prospective cohort of adult patients with persistent air leaks (PALs) undergoing bronchoscopy. The intervention evaluated is a combination approach that includes endobronchial valve placement and instillation of autologous blood with tranexamic acid (TXA), followed by balloon occlusion (referred to as "PATCHVALVE" technique). Patients will be enrolled and undergo standard imaging and procedural evaluations. For prospective participants, informed consent will be obtained prior to the procedure. Procedural steps include: * Identification of the leaking segment using imaging and air leak assessment. * Instillation of fresh autologous blood (up to 30 mL) followed by TXA (up to 10 mL) via a balloon catheter into the leaking airway segment. * Balloon occlusion for 3-5 minutes to promote clotting and adherence. * Deployment of endobronchial valves based on standard criteria. * Leak reassessment and iterative treatment if necessary. This study will provide early evidence on the efficacy of this combined approach and help standardize care protocols for managing PALs non-surgically.

Conditions

• Persistent Air Leaks

Interventions

Type	Name	Description
DEVICE	Endobronchial Blood Patch	This component of the procedure involves sealing persistent air leak (PAL) defects using autologous blood delivered via a balloon catheter. After identifying the target segment, carefully noting the airway angle and distal carina, a sizing balloon is deployed and inflated to ensure a tight seal. Under anesthesia, 30 mL of fresh blood is prepared and infused into the target airway until either visible extravasation occurs or the full volume is delivered. Following this, up to 10 mL of tranexamic acid (TXA) may be administered, again until extravasation occurs or the volume is fully instilled. The balloon remains inflated for 3-5 minutes after the instillation to allow clot formation and sealing of the defect.
DEVICE	Spiration Valve System (SVS) Placement	Once the blood patch component is complete and the balloon is deflated, a Spiration Valve System (SVS) is placed proximally in the airway. The valve acts as a one-way device that decompresses the targeted lung segment while stabilizing the clot created by the blood patch. This supports durable resolution of the air leak, particularly in cases where collateral ventilation might otherwise reduce the efficacy of valve therapy alone.

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-07-01
• Completion: 2027-07-01
• First posted: 2025-09-22
• Last updated: 2025-09-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study