Thopaz for PALs Evaluation
Recruiting now
Conditions studied: Persistent Air Leaks
In brief
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.
Key facts
- Study ID
- NCT07105436
- Run by
- Kai Swenson
- People needed
- 20
- Starts
- 2026-01-01
- Expected to finish
- 2026-09-01
- Last updated by the study team
- 2026-03-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years
- Hospitalized with a persistent air leak (PAL) lasting ≥5 days despite continuous chest tube drainage.
- Undergoing bronchoscopy as part of clinical care for PAL management.
- Able and willing to provide written informed consent
You may not qualify if…
- Contraindications to bronchoscopy or EBV placement.
- Pregnancy.
- Inability to tolerate general anesthesia.
Where it is running
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
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