Recruiting

Thopaz+

Sponsor:

Kai Swenson

Code:

NCT07105436

Conditions

Persistent Air Leaks

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Persistent air leak quantification

Study Details

Brief summary:

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

Persistent Air Leaks

Study ID

NCT07105436

Start date

Jan 1, 2026

Status verified date

Mar, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Interventions

Persistent air leak quantification

In this trial, patients with PALs will have their chest tubes connected to the Thopaz+ system. The Thopaz+ will continuously quantify the volume of air leaks, providing real-time data for analysis.

Data from both the Thopaz+ and standard serial occlusion test with Fogarty balloon will be combined and integrated to provide a comprehensive assessment of the air leak source. The bronchoscopic will perform standard visual assessment of changes in air leak during serial balloon occlusion in order to identify the best region for endobronchial treatments; use of measurements from the Thopaz and serial balloon occlusion test will be allowed as part of clinical reasoning but are not required to be used by the treating clinician.

Primary outcome measure

  • Number of Participants with Successful Intraoperative Quantification of Air Leak Volume Using Thopaz+ Digital Drainage System [ Time Frame: During procedure ]

Central Contacts and Locations

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

More Information

Sponsor

Kai Swenson

Last update posted

Mar 17, 2026

Last verified

Mar, 2026

Keywords

  • Persistent Air Leaks
  • Chest Tube
  • Waterseal
  • Thopaz+

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kai Swenson on 2026-03-17.