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Thopaz for PALs Evaluation

Utility of the Thopaz+ System in Evaluating Persistent Air Leaks

Who can join

Ages 18 and older · All sexes

Inclusion Criteria:

* 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

Exclusion Criteria:

* Contraindications to bronchoscopy or EBV placement.
* Pregnancy.
* Inability to tolerate general anesthesia.

About the study

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.

What is being tested

• Persistent air leak quantification (diagnostic test)

Sponsor: Kai Swenson · Participants: 20 · Started: Jan 1, 2026

Contact the study team

• Kai Swenson, MD · Phone: 617-632-8386

Official record on ClinicalTrials.gov — NCT07105436

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.