AzTrials
AzTrials

Persistent Air LeaksNCT07184528

PATCHVALVE: Endobronchial Valves Plus Blood Patch for Persistent Air Leaks

A study testing Endobronchial Blood Patch and Spiration Valve System (SVS) Placement in people with Persistent Air Leaks, run by Beth Israel Deaconess Medical Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Persistent Air Leaks
What is being tested?
Endobronchial Blood Patch and Spiration Valve System (SVS) Placement
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
1 Jul 2025to 1 Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

{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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jason Beattie, MD contact

3105298266

jbeattie@bidmc.harvard.edu

Christine Conley, MD contact

cconley@bidmc.harvard.edu

United States1 site, 1 recruiting

  • Beth Isreal Deaconess Medical Center

    Boston, Massachusetts, 02215

    Beth Isreal Deaconess Medical Center, (617) 667-7000, NIBCHI@bidmc.harvard.edu

    Christine Conley, MD, cconley@bidmc.harvard.edu

    Recruiting

Other trials in United States

About this study

Official title: PATCHVALVE Trial: A Prospective Evaluation of Blood Patch and Endobronchial Valves for Persistent Air Leaks - Pilot Study

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:

Read more
  • 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.
Read the 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.

Being tested
Endobronchial Blood Patch, Spiration Valve System (SVS) Placement
Keywords
persistent air leaks, Endobronchial Valves, Spiration Valve System, Endobronchial Blood Patch, Intrabronchial Valves

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endobronchial Blood PatchDevice

    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) PlacementDevice

    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.

Study groups in NCT07184528
Study groupRoleWhat they receive
Bronchoscopic Endobronchial Valve and Blood Patch Treatment Group for Persistent Air Leak ManagementExperimentalThis 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.
Receives: Device: Endobronchial Blood Patch; Device: Spiration Valve System (SVS) Placement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Adverse Events Following Combined Blood Patch and Spiration Valve Application

    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)

    Measured: From enrollment to the end of the observational period at 12 months post-intervention as per standard procedure

  2. Feasibility of Combined Endobronchial Blood Patch and Spiration Valve Procedure

    Defined as the successful completion of the combined autologous endobronchial blood patch and Spiration Valve procedure.

    Units: Binary (Yes/No - Procedure Completed as Intended)

    Measured: From enrollment to end of procedure.

Secondary outcomes (6)

  1. Change in Air Leak Severity Based on Cerfolio Classification

    This refers to the variation or progression in postoperative pulmonary air leaks, categorized based on the Cerfolio classification system. Units: Change in Cerfolio Grade (e.g., Grade 4 to Grade 2)

    Measured: From enrollment to end of observational period at 12 months post-intervention as per standard procedure

  2. Time to Air Leak Resolution

    Duration from the onset of a postoperative air leak to its complete cessation. Units: Days

    Measured: From enrollment to end of observational period at 12 months post-intervention as per standard procedure.

  3. Change in Chest Tube Suction Requirement

    This denotes the alteration in the level or need for suction applied to a chest drainage system over time. Units: cmH₂O

    Measured: From enrollment to end of observational period at 12 months post-intervention as per standard procedure

  4. Time to Chest Tube Removal

    Duration from intervention to successful removal of the chest tube, indicating resolution of the persistent air leak and adequate lung re-expansion. Units: Days

    Measured: From enrollment to end of observational period at 12 months post-intervention as per standard procedure

  5. Subsequent Interventions Required Following Blood Patch and Valve Treatment

    Incidence and nature of additional therapeutic procedures required to manage persistent air leaks following the initial combined blood patch and valve intervention. Units: Number of participants requiring ≥1 additional intervention

    Measured: From enrollment to end of observational period at 12 months post-intervention as per standard procedure

  6. Incidence of Respiratory Infections Following Combined Blood Patch and Spiration Valve Application

    This outcome will specifically evaluate the number of participants who develop respiratory infections following the intervention. Respiratory infections of interest include post-obstructive pneumonia and other clinically documented respiratory infections potentially related to the procedure.

    Units: Binary (YES/NO)

    Measured: From enrollment to the end of the observational period at 12 months post-intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2025
  2. Study start1 Jul 2025
  3. Primary completion1 Jul 2026 (estimated)
  4. Study completion1 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07184528
Sponsor's protocol ID
2025P000315
Status last verified
Sep 2025
First submitted
25 Aug 2025
Last updated
22 Sep 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Durrance RJ, D'Souza KG, Obata R, Bradley EC, Perwaiz MK. Endobronchial blood-patch: A novel technique for a persistent pleural air leak. Respir Med Case Rep. 2022 May 28;38:101670. doi: 10.1016/j.rmcr.2022.101670. eCollection 2022.

    PubMed 35656093

  • Watanabe S, Watanabe T, Urayama H. Endobronchial occlusion method of bronchopleural fistula with metallic coils and glue. Thorac Cardiovasc Surg. 2003 Apr;51(2):106-8. doi: 10.1055/s-2003-38981.

    PubMed 12730823

  • Takaoka K, Inoue S, Ohira S. Central bronchopleural fistulas closed by bronchoscopic injection of absolute ethanol. Chest. 2002 Jul;122(1):374-8. doi: 10.1378/chest.122.1.374.

    PubMed 12114386

  • Lopez C, Facciolo F, Lequaglie C, Rendina EA, Saita S, Dell'Amore D, Sollitto F, Urciuoli G, Loizzi M, Cisternino ML, Granone P, Angelelli A, Cardillo G, Mucilli F, Di Rienzo G. Efficacy and safety of fibrin sealant patch in the treatment of air leakage in thoracic surgery. Minerva Chir. 2013 Dec;68(6):559-67.

    PubMed 24193288

  • Thistlethwaite PA, Luketich JD, Ferson PF, Keenan RJ, Jamieson SW. Ablation of persistent air leaks after thoracic procedures with fibrin sealant. Ann Thorac Surg. 1999 Feb;67(2):575-7. doi: 10.1016/s0003-4975(98)01292-2.

    PubMed 10197706

  • Majid A, Kheir F, Sierra-Ruiz M, Ghattas C, Parikh M, Channick C, Keyes C, Chee A, Fernandez-Bussy S, Gangadharan S, Folch E. Assessment of Fissure Integrity in Patients With Intrabronchial Valves for Treatment of Prolonged Air Leak. Ann Thorac Surg. 2019 Feb;107(2):407-411. doi: 10.1016/j.athoracsur.2018.08.046. Epub 2018 Oct 10.

    PubMed 30315804

  • Ding M, Gao YD, Zeng XT, Guo Y, Yang J. Endobronchial one-way valves for treatment of persistent air leaks: a systematic review. Respir Res. 2017 Nov 6;18(1):186. doi: 10.1186/s12931-017-0666-y.

    PubMed 29110704

  • Gillespie CT, Sterman DH, Cerfolio RJ, Nader D, Mulligan MS, Mularski RA, Musani AI, Kucharczuk JC, Gonzalez HX, Springmeyer SC. Endobronchial valve treatment for prolonged air leaks of the lung: a case series. Ann Thorac Surg. 2011 Jan;91(1):270-3. doi: 10.1016/j.athoracsur.2010.07.093.

    PubMed 21172529

  • Mahajan AK, Khandhar SJ. Bronchoscopic valves for prolonged air leak: current status and technique. J Thorac Dis. 2017 Mar;9(Suppl 2):S110-S115. doi: 10.21037/jtd.2016.12.63.

    PubMed 28446973

  • Dugan KC, Laxmanan B, Murgu S, Hogarth DK. Management of Persistent Air Leaks. Chest. 2017 Aug;152(2):417-423. doi: 10.1016/j.chest.2017.02.020. Epub 2017 Mar 4.

    PubMed 28267436

  • Johnson BH, Johnston SS, Tewari P, Afolabi M, Danker Iii W. Clinical and Economic Burden Associated with Prolonged Air Leaks Among Patients Undergoing Thoracic Resection: A Retrospective Database Analysis. Clinicoecon Outcomes Res. 2023 Apr 11;15:269-280. doi: 10.2147/CEOR.S405270. eCollection 2023.

    PubMed 37070065

  • Chee CB, Abisheganaden J, Yeo JK, Lee P, Huan PY, Poh SC, Wang YT. Persistent air-leak in spontaneous pneumothorax--clinical course and outcome. Respir Med. 1998 May;92(5):757-61. doi: 10.1016/s0954-6111(98)90008-7.

    PubMed 9713636

  • Huang X, Ding L, Xu H. Bronchoscopic valve placement for the treatment of persistent air leaks. Medicine (Baltimore). 2018 Mar;97(13):e0183. doi: 10.1097/MD.0000000000010183.

    PubMed 29595651

  • Lazarus DR, Casal RF. Persistent air leaks: a review with an emphasis on bronchoscopic management. J Thorac Dis. 2017 Nov;9(11):4660-4670. doi: 10.21037/jtd.2017.10.122.

    PubMed 29268535

Questions about this trial

What is this clinical trial studying?

A study testing Endobronchial Blood Patch and Spiration Valve System (SVS) Placement in people with Persistent Air Leaks, run by Beth Israel Deaconess Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jason Beattie, MD (3105298266, jbeattie@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07184528, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in