Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-31 @ 7:19 PM
Study NCT ID:
NCT07184528
Status:
RECRUITING
Last Update Posted:
2025-09-22
First Post:
2025-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PATCHVALVE: Endobronchial Valves Plus Blood Patch for Persistent Air Leaks
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Study Overview
Official Title:
PATCHVALVE Trial: A Prospective Evaluation of Blood Patch and Endobronchial Valves for Persistent Air Leaks - Pilot Study
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: