Actively Recruiting
Thopaz for PALs Evaluation
Led by Kai Swenson · Updated on 2026-03-17
20
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
Sponsors
K
Kai Swenson
Lead Sponsor
B
Beth Israel Deaconess Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Persistent air leaks (PALs) are a common postoperative complication resulting from tears in the visceral pleura or peripheral lung resections. Although highly prevalent with significant consequences, traditional assessment methods lack the capability to objectively quantify air leaks, which further complicates management, results in inconsistent decision making, and prolongs hospital stays. By incorporating the Thopaz+ system, the investigators can introduce a reliable approach to objectively quantify air leaks, potentially improving clinical outcomes. The purpose of this protocol is to perform a pilot prospective controlled clinical trial to evaluate the utility of incorporating the Thopaz+ system and its volume quantification ability in evaluating patients with persistent air leaks (PALs) to guide treatment decisions, specifically endobronchial valves (EBVs). In the targeted cohort, the Thopaz+ will be connected to the chest tube and the data collected will be combined with that of serial balloon occlusion testing with a Fogarty balloon to accurately localize the air leak source, and subsequently consider the correct placement of EBVs. The investigators will thereby determine whether this experimental strategy will yield a more accurate and objective assessment of air leaks, facilitating timely interventions and improved patient outcomes.
CONDITIONS
Official Title
Thopaz for PALs Evaluation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Hospitalized with a persistent air leak lasting 5 days or more despite continuous chest tube drainage
- Undergoing bronchoscopy as part of clinical care for persistent air leak management
- Able and willing to provide written informed consent
You will not qualify if you...
- Contraindications to bronchoscopy or endobronchial valve placement
- Pregnancy
- Inability to tolerate general anesthesia
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
K
Kai Swenson, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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