PATCHVALVE Trial: A Prospective Evaluation of Blood Patch and Endobronchial Valves for Persistent Air Leaks - Pilot Study
Sponsor study identifier
interventional
20
1 country
1
Study Start
July 1, 2025
Actual (reported)Primary Completion
July 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 1, 2025
Actual (reported)August 25, 2025
Actual (reported)September 22, 2025
Actual (reported)July 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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)
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
Defined as the successful completion of the combined autologous endobronchial blood patch and Spiration Valve procedure. Units: Binary (Yes/No - Procedure Completed as Intended)
From enrollment to end of procedure.
Change in Air Leak Severity Based on Cerfolio Classification
From enrollment to end of observational period at 12 months post-intervention as per standard procedure
Time to Air Leak Resolution
From enrollment to end of observational period at 12 months post-intervention as per standard procedure.
Change in Chest Tube Suction Requirement
From enrollment to end of observational period at 12 months post-intervention as per standard procedure
Time to Chest Tube Removal
From enrollment to end of observational period at 12 months post-intervention as per standard procedure
Subsequent Interventions Required Following Blood Patch and Valve Treatment
From enrollment to end of observational period at 12 months post-intervention as per standard procedure
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.
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.
Beth Isreal Deaconess Medical Center
Boston, Massachusetts, 02215, United States
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.
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.
Jason Beattie, MD
Beth Israel Deaconess Medical Center
First Submitted
August 25, 2025
First Posted
September 22, 2025
Study Start
July 1, 2025
Actual (reported)Primary Completion
July 1, 2026
Estimated (date passed)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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 22, 2025
Record last verified: 2025-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: