PATCHVALVE: Endobronchial Valves Plus Blood Patch for Persistent Air Leaks

Beth Israel Lahey Health

Status: Enrolling

Conditions: Persistent Air Leaks

Treatments: Device: Spiration Valve System (SVS) Placement; Device: Endobronchial Blood Patch

Study type: Interventional

Funder types: Other

Identifiers

NCT07184528

2025P000315

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Bronchoscopic Endobronchial Valve and Blood Patch Treatment Group for Persistent Air Leak Management

Experimental group

Description:

This study will enroll patients with persistent air leaks (PAL) following lung resection or unrelated to lung resection, who have ipsilateral chest tubes in place and are either not suitable candidates for surgical intervention or have declined surgery. Participants will undergo a combined bronchoscopic approach involving endobronchial valve (EBV) placement and endobronchial blood-patch application, aiming to effectively manage air leaks through a minimally invasive, nonsurgical technique.

Treatment:

Device: Endobronchial Blood Patch

Device: Spiration Valve System (SVS) Placement