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NCT06035120 · ClinicalTrials.gov registry record · NA
An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema
A NA study of Emphysema or COPD and Emphysema, Pulmonary, sponsored by Pulmonx Corporation.
- Recruiting
- Registry status
- NA
- Development phase
- 200
- Enrollment target
- 20
- Study locations
NCT06035120: Recruiting NA study of Emphysema or COPD and Emphysema, Pulmonary, sponsored by Pulmonx Corporation.
NCT06035120 is a NA study of Emphysema or COPD and Emphysema, Pulmonary that is actively recruiting participants, run by Pulmonx Corporation. The registered enrollment target is 200 participants, above the 46-participant average among 7 other Emphysema or COPD trials with a reported enrollment target (335% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06035120, a NA study of Emphysema or COPD and Emphysema, Pulmonary, is actively recruiting participants, sponsored by Pulmonx Corporation.
- RECRUITING
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a prospective, open-label, multi-center, single-arm study planned to enroll 200 subjects with heterogeneous emphysema and collateral ventilation (CV) in the target lobe. Subjects will undergo instillation of AeriSeal Foam in the target lobe and subsequent assessment of CV status using Chartis Pulmonary Assessment System. Subjects with CV- status will then undergo placement of Zephyr Valve in the target lobe for bronchoscopic lung volume reduction (BLVR) and be followed for 24 months.
Primary Outcome
The percentage of study subjects that successfully convert from a positive collateral ventilation status (CV+) in the treated lobe to having little to no collateral ventilation (CV-) by Chartis.
Conditions Studied
Interventions
- DEVICE AeriSeal System
Study Locations (20)
Pennsylvania
- Penn Medicine - Philadelphia
- Temple University - Philadelphia
- Allegheny General Hospital - Pittsburgh
- University of Pittsburgh Medical Center (UPMC) - Pittsburgh
Illinois
- Northwestern University - Chicago
- University of Chicago Medical Center - Chicago
- OSF Saint Francis Medical Center - Peoria
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
- Brigham Lung Center - Boston
Australia
- Royal Adelaide Hospital - Adelaide
- Wesley Hospital - Brisbane
Arizona
- Banner University Medical Center - Phoenix
Connecticut
- Saint Francis Hospital and Medical Center (Trinity Health of New England) - Hartford
Florida
- Orlando Health - Orlando
Michigan
- Henry Ford Hospital - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2024-02-22 |
| Est. Completion | 2028-03-31 |
| Phase | NA |
What NCT06035120 shows while recruiting
NCT06035120 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, above the 46-participant average among 7 other Emphysema or COPD trials with a reported enrollment target (335% higher).
The record links to 2 conditions, with Emphysema or COPD appearing as the primary indexed condition, and to 1 intervention - of which AeriSeal System is the first listed.
NCT06035120 names 20 study sites across 13 states, led by Pennsylvania, Illinois, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06035120 about?
NCT06035120 is a clinical study titled "An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema". This is a prospective, open-label, multi-center, single-arm study planned to enroll 200 subjects with heterogeneous emphysema and collateral ventilation (CV) in the target lobe. Subjects will undergo instillation of AeriSeal Foam in the target lobe and subsequent assessment of CV status using Charti...
What is the current status of trial NCT06035120?
This trial is currently recruiting. It is a NA study. The enrollment target is 200 participants. The study started on 2024-02-22. Estimated completion is 2028-03-31.
What conditions does trial NCT06035120 study?
This clinical trial studies the following conditions: Emphysema or COPD, Emphysema, Pulmonary.
What interventions are being tested in trial NCT06035120?
The interventions under investigation include: AeriSeal System (DEVICE).
Who is sponsoring clinical trial NCT06035120?
This trial is sponsored by Pulmonx Corporation, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06035120 being conducted?
This trial has 20 study locations across Arizona, Connecticut, Florida, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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