PATCHVALVE: Endobronchial Valves Plus Blood Patch for Persistent Air Leaks

NARecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

July 1, 2025

Primary Completion Date

July 1, 2026

Study Completion Date

July 1, 2027

Conditions
Persistent Air Leaks
Interventions
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.

Trial Locations (1)

02215

RECRUITING

Beth Isreal Deaconess Medical Center, Boston

All Listed Sponsors
lead

Beth Israel Deaconess Medical Center

OTHER