Persistent Air LeaksNCT07105436
Thopaz for PALs Evaluation
An observational study of Persistent Air Leaks, run by Kai Swenson at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Air Leaks
- What is being tested?
- Persistent air leak quantification
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2026to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Contraindications to bronchoscopy or EBV placement.
- Pregnancy.
- Inability to tolerate general anesthesia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Kai Swenson, MD, 617-632-8386, BIDMC-IPResearchTeam@bidmc.harvard.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Persistent Air Leaks
- Being tested
- Persistent air leak quantification
- Keywords
- Persistent Air Leaks, Chest Tube, Waterseal, Thopaz+
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Persistent air leak quantificationDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Successful Intraoperative Quantification of Air Leak Volume Using Thopaz+ Digital Drainage System
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.
Measured: During procedure
Secondary outcomes (10)
Percentage of patients with identifiable lobar or segmental airways responsible for PAL
Percentage of patients with identifiable lobar or segmental airways responsible for PAL
Measured: During procedure
Maximum decrease in volume of air leak during serial balloon occlusion, as measured by Thopaz+ device
Measured: During procedure
Treatment success: decrease of one grade in Cerfolio classification for air leaks or removal of continuous suction from chest drain.
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
Measured: 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
Measured: From enrollment until 8 weeks follow-up (as per standard of care for bronchoscopic treatment of PALs)
Length of stay following EBV placement
Measured: From enrollment until 8 weeks follow-up (as per standard of care for bronchoscopic treatment of PALs)
Duration of chest tube following bronchoscopy
Measured: 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
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
Measured: 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
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.
Measured: From enrollment until 8 weeks follow-up (as per standard of care for bronchoscopic treatment of PALs)
The need for additional non-surgical intervention
Measured: 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
Measured: From enrollment until 8 weeks follow-up (as per standard of care for bronchoscopic treatment of PALs)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start1 Jan 2026
- Primary completionJun 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Air LeaksStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kai Swenson
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center
- Responsible party
- Sponsor-investigator, Kai Swenson, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07105436
- Sponsor's protocol ID
- 2024P001113
- Status last verified
- Mar 2026
- First submitted
- 18 Jun 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of the Thopaz+ System in Evaluating Persistent Air Leaks
- ClinicalTrials.gov ID
- NCT07105436
- Acronym / sponsor ID
- 2024P001113
- Conditions
- Persistent Air Leaks
- Keywords
- Persistent Air Leaks, Chest Tube, Waterseal, Thopaz+
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kai SwensonUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Contraindications to bronchoscopy or EBV placement.
- Pregnancy.
- Inability to tolerate general anesthesia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Persistent air leak quantificationIn 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. | Diagnostic test | – |
Primary outcome
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.
10 secondary outcomes
Percentage of patients with identifiable lobar or segmental airways responsible for PAL
Time frame: During procedure
Maximum decrease in volume of air leak during serial balloon occlusion, as measured by Thopaz+ device
Time frame: 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)
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)
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)
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)
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)
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 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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
Related trials for Persistent Air Leaks
Recruiting
PATCHVALVE: Endobronchial Valves Plus Blood Patch for Persistent Air Leaks
Persistent Air Leaks
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Persistent Air Leaks, run by Kai Swenson at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kai Swenson, MD (617-632-8386, BIDMC-IPResearchTeam@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Successful Intraoperative Quantification of Air Leak Volume Using Thopaz+ Digital Drainage System (time frame: During procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.