| NCT ID | NCT07105436 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kai Swenson |
| Condition | Persistent Air Leaks |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2026-01-01 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07105436 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Persistent Air Leaks. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07105436 currently recruiting?
Yes, NCT07105436 is actively recruiting participants. Contact the research team at BIDMC-IPResearchTeam@bidmc.harvard.edu for enrollment information.
Where is the NCT07105436 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT07105436 clinical trial?
NCT07105436 is sponsored by Kai Swenson. The trial plans to enroll 20 participants.