Thopaz for PALs Evaluation

March 15, 2026 updated by: Kai Swenson

Utility of the Thopaz+ System in Evaluating Persistent Air Leaks

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The investigators will conduct a prospective controlled clinical trial. The investigators' target demographic includes all adult patients with lung resection and/or non-lung resection-related PAL with ipsilateral chest tubes who were not candidates for surgical intervention or patients who refused the intervention. These patients would undergo a multidisciplinary review by thoracic surgery, interventional pulmonary and the primary care team to consider a bronchoscopic approach with endobronchial valves and possibly bronchial blood patch, which is currently considered standard of care at our institution. During this standard-of-care intervention, quantitative assessment of distal occluded airway pressures/flows in various airways, as well as quantitative assessment of air leak volume will be assessed.

In current medical practice, when EBVs are considered in the context of managing PALs, bronchoscopists may opt to either conduct complete lobar occlusion (sealing of all segments within the target lobe) or segmental occlusion (sealing only selected segments within the target lobe). The decision is usually guided by localizing the source of air leak which is usually done by monitoring the reduction of air leak on the pleural drainage device following serial inflation of a Fogarty Catheter at various locations within the endobronchial tree and monitoring change in air leak visually in the pleural drainage system.

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 bronchoscopist 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.

Continuous monitoring using the Thopaz+ system may continue post-procedure to track changes in air leak volumes and patient recovery, ensuring timely interventions and optimal patient outcomes. This integrated approach aims to provide a more accurate, objective, and efficient method of managing PALs compared to traditional techniques.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All study subjects will be patients who meet the inclusion criteria including a willingness to read, understand, and sign the informed consent. Recruitment of study subjects will be from the pool of admitted patients from our inpatient service. They will be recruited in a consecutive fashion from the clinical practices of the investigators from BIDMC.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants with Successful Intraoperative Quantification of Air Leak Volume Using Thopaz+ Digital Drainage System
Time Frame: During procedure
Feasibility will be defined by the ability to obtain continuous, interpretable quantitative air leak volume data (in mL/min) during bronchoscopic evaluation of persistent air leaks. Successful quantification is defined as capturing measurable air leak volume data during serial balloon occlusion in at least one airway segment. The outcome will be reported as the number and percentage of participants with successful measurements out of the total enrolled population.
During procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of patients with identifiable lobar or segmental airways responsible for PAL
Time Frame: During procedure
Percentage of patients with identifiable lobar or segmental airways responsible for PAL
During procedure
Maximum decrease in volume of air leak during serial balloon occlusion, as measured by Thopaz+ device
Time Frame: During procedure
During procedure
Treatment success: decrease of one grade in Cerfolio classification for air leaks or removal of continuous suction from chest drain.
Time Frame: From enrollment until 8 weeks follow-up (as per standard of care for bronchoscopic treatment of PALs)
The Cerfolio classification categorizes air leaks based on their occurrence during the respiratory cycle, with grades 1-4 indicating increasing severity. Grade 1 is a forced expiratory leak, seen during coughing; Grade 2, expiratory; Grade 3, inspiratory; and Grade 4, continuous during both inspiration and expiration
From enrollment until 8 weeks follow-up (as per standard of care for bronchoscopic treatment of PALs)
Treatment failure: no decrease in the degree of the air leak (Cerfolio classification) and the need for continuous suction for chest drain
Time Frame: From enrollment until 8 weeks follow-up (as per standard of care for bronchoscopic treatment of PALs)
From enrollment until 8 weeks follow-up (as per standard of care for bronchoscopic treatment of PALs)
Length of stay following EBV placement
Time Frame: From enrollment until 8 weeks follow-up (as per standard of care for bronchoscopic treatment of PALs)
From enrollment until 8 weeks follow-up (as per standard of care for bronchoscopic treatment of PALs)
Duration of chest tube following bronchoscopy
Time Frame: From enrollment until 8 weeks follow-up (as per standard of care for bronchoscopic treatment of PALs)
From enrollment until 8 weeks follow-up (as per standard of care for bronchoscopic treatment of PALs)
Change in Air Leak Severity Graded by Cerfolio Classification
Time Frame: From enrollment until 8 weeks follow-up (as per standard of care for bronchoscopic treatment of PALs)
The Cerfolio classification categorizes air leaks based on their occurrence during the respiratory cycle, with grades 1-4 indicating increasing severity. Grade 1 is a forced expiratory leak, seen during coughing; Grade 2, expiratory; Grade 3, inspiratory; and Grade 4, continuous during both inspiration and expiration
From enrollment until 8 weeks follow-up (as per standard of care for bronchoscopic treatment of PALs)
Change in Quantitative Air Leak Volume Measured by Thopaz+ Digital Drainage System
Time Frame: From enrollment until 8 weeks follow-up (as per standard of care for bronchoscopic treatment of PALs)
The Thopaz+ device will be used to continuously measure the volume of air leak (in mL/min) before and after bronchoscopic intervention. The outcome will report the change in air leak volume from baseline (pre-bronchoscopy) to post-bronchoscopy values.
From enrollment until 8 weeks follow-up (as per standard of care for bronchoscopic treatment of PALs)
The need for additional non-surgical intervention
Time Frame: From enrollment until 8 weeks follow-up (as per standard of care for bronchoscopic treatment of PALs)
From enrollment until 8 weeks follow-up (as per standard of care for bronchoscopic treatment of PALs)
The need for additional surgical intervention for PAL such as video-assisted thoracoscopic surgery with mechanical pleurodesis, blebectomy or lobectomy
Time Frame: From enrollment until 8 weeks follow-up (as per standard of care for bronchoscopic treatment of PALs)
From enrollment until 8 weeks follow-up (as per standard of care for bronchoscopic treatment of PALs)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kai Swenson

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Beth Israel Deaconess Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024P001113

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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