Thopaz+ measurement of persistent air leaks after lung surgery
Official title: Utility of the Thopaz+ System in Evaluating Persistent Air Leaks
Run by Beth Israel Deaconess Medical Center · NCT07105436 · Data updated 2026-11-12
This pilot will test whether connecting the Thopaz+ device to chest tubes can help doctors decide if endobronchial valves will fix persistent air leaks in hospitalized adults.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | January 1, 2026 |
| Main results expected | July 1, 2027 |
| Study ends | October 1, 2027 |
| Registry record updated | November 10, 2026 |
| Trial ID | NCT07105436 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Hospitalized adults aged 18 or older with a persistent air leak lasting at least five days, who are undergoing bronchoscopy for PAL management and can give informed consent are eligible.
✕Probably not a fit
Patients who are candidates for surgical repair, have contraindications to bronchoscopy or EBV placement, are pregnant, or cannot tolerate general anesthesia are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, controlled pilot trial enrolling adult inpatients with persistent air leaks of at least five days who are undergoing bronchoscopy as part of their care. The Thopaz+ digital drainage system will be attached to patients' chest tubes to capture objective, quantitative air-leak volume and flow data during bronchoscopic maneuvers. Those data will be combined with standard bronchoscopic localization techniques (including distal airway occlusion and pressure/flow measurements) to guide decisions about endobronchial valve placement or bronchial blood patch. Outcomes will include the usefulness of quantitative leak measurements for localization, procedural decision-making, and clinical endpoints such as chest-tube duration and hospital length of stay.
Why it matters
Potential benefit: If successful, the approach could standardize localization of air leaks, speed appropriate valve placement, and shorten chest-tube duration and hospital stays.
How similar studies have gone: Digital drainage systems and balloon-occlusion localization have been used previously to support decision-making, but using Thopaz+ volume quantification specifically to guide endobronchial valve placement is a novel, pilot application.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States Recruiting
Study contacts
- Study coordinator: Kai Swenson, MD
- Email: BIDMC-IPResearchTeam@bidmc.harvard.edu
- Phone: 617-632-8386
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Endobronchial valves with an airway blood patch for persistent air leaks
This study will try combining an airway blood patch with endobronchial valves to stop persistent air leaks in adults who cannot or do not want surgery.
-
Daily 7-Minute Digital Meditation for Young Adults
A short daily, app-based meditation test in 18-40 year-olds in the US to see if it improves mood, stress, and well-being.
-
How regular meditation relates to thinking and emotion control
This study will see if people who regularly practice Isha-style meditation differ in cognitive skills and emotion regulation compared with people who do not meditate.
-
Measuring muscle health with a handheld electrical impedance device (mScan)
This project will test whether a handheld mScan device can quickly measure muscle health in adults with myopathies and in people without muscle disease by comparing its readings to MRI.
-
Reverse leftover spinal numbness after knee or hip replacement with an intrathecal saline flush
This study tests whether injecting a small amount of sterile saline through a spinal catheter can quickly reduce or eliminate leftover spinal anesthesia in adults having elective lower-extremity joint replacement.
-
Seeing if DCog Short on an iPad can spot neurotoxicity in CAR-T patients
This study tests whether a self-report iPad tool called DCog Short can help identify neurotoxicity in people receiving CAR-T cell therapy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.