Recruiting

IBV & EBP

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT07184528

Conditions

Persistent Air Leaks

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Endobronchial Blood Patch

Spiration Valve System (SVS) Placement

Study Details

Brief 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.

Conditions

Persistent Air Leaks

Study ID

NCT07184528

Start date

Jul 1, 2025

Status verified date

Sep, 2025

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jul 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

{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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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.

Interventions

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.

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.

Primary outcome measure

  • Incidence of Adverse Events Following Combined Blood Patch and Spiration Valve Application [ Time Frame: From enrollment to the end of the observational period at 12 months post-intervention as per standard procedure ]
  • Feasibility of Combined Endobronchial Blood Patch and Spiration Valve Procedure [ Time Frame: From enrollment to end of procedure. ]

Central Contacts and Locations

Central contacts

Jason Beattie, MD

3105298266jbeattie@bidmc.harvard.edu

Christine Conley, MD

cconley@bidmc.harvard.edu

Locations

Beth Isreal Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Beth Isreal Deaconess Medical Center

(617) 667-7000NIBCHI@bidmc.harvard.edu

Christine Conley, MD

cconley@bidmc.harvard.edu

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

Sep 22, 2025

Last verified

Sep, 2025

Keywords

  • persistent air leaks
  • Endobronchial Valves
  • Spiration Valve System
  • Endobronchial Blood Patch
  • Intrabronchial Valves

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2025-09-22.