An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- Pulmonx Corporation
- Study ID
- NCT06035120
- Status
- Recruiting
Conditions
- Emphysema or COPD
- Emphysema, Pulmonary
Eligibility Criteria
- Sex
- ALL
- Age
- 40 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- AeriSeal System — DEVICEThe AeriSeal System comprises AeriSeal Foam and the AeriSeal Balloon Catheter Preparation Kit that is used for bronchoscopic delivery of AeriSeal Foam to the targeted regions of the lung.
Study Details
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.
Key Dates
- Start date
- Feb 22, 2024
- Status verified
- Mar 2026
- Primary completion
- Jun 30, 2027
- Completion
- Mar 31, 2028
Study Design
- Enrollment
- 200 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: AeriSealAll enrolled subjects meeting final eligibility will undergo the AeriSeal procedure to block collateral ventilation by closing the lobar fissure gaps or collateral air channels.
Primary Outcome Measure
Converters, responder rate [ Time Frame: 45 days post-AeriSeal treatment (index or repeat) ]
Central Contacts
- Christina Kutzavitch, PhD+1 650-216-0134
- Marie Barrigar
Locations (18)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Banner University Medical Center | Phoenix | Arizona | 85006 | Raed Alalawi, MD Raed Alalawi, MD (PRINCIPAL_INVESTIGATOR) |
| Saint Francis Hospital and Medical Center (Trinity Health of New England) | Hartford | Connecticut | 06105 | Anil Magge, MD (PRINCIPAL_INVESTIGATOR) |
| Orlando Health | Orlando | Florida | 32806 | Mark Vollenweider, MD Mark Vollenweider, MD (PRINCIPAL_INVESTIGATOR) |
| Northwestern University | Chicago | Illinois | 60611 | Momen Wahidi, MD Momen Wahidi, MD (PRINCIPAL_INVESTIGATOR) |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | Ajay Wagh, MD Ajay Wagh, MD (PRINCIPAL_INVESTIGATOR) |
| OSF Saint Francis Medical Center | Peoria | Illinois | 61606 | Patrick Whitten, MD Patrick Whitten, MD (PRINCIPAL_INVESTIGATOR) |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02115 | Adnan Majid, MD Adnan Majid, MD (PRINCIPAL_INVESTIGATOR) |
| Brigham Lung Center | Boston | Massachusetts | 02115 | - |
| Henry Ford Hospital | Detroit | Michigan | 48202 | Avi Cohen Avi Cohen, MD (PRINCIPAL_INVESTIGATOR) |
| Cleveland VA Northeast | Cleveland | Ohio | 44106 | - |
| Penn Medicine | Philadelphia | Pennsylvania | 19107 | Kevin Ma, MD Kevin Ma, MD (PRINCIPAL_INVESTIGATOR) |
| Temple University | Philadelphia | Pennsylvania | 19140 | Gerard Criner Gerard Criner, MD (PRINCIPAL_INVESTIGATOR) |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | Stephanie Baltaji, MD Stephanie Baltaji, MD (PRINCIPAL_INVESTIGATOR) |
| University of Pittsburgh Medical Center (UPMC) | Pittsburgh | Pennsylvania | 15213 | Frank Sciurba, MD Frank Sciurba, MD (PRINCIPAL_INVESTIGATOR) |
| Fort Sanders Regional Medical Center (StatCare) | Knoxville | Tennessee | 37916 | Varun Shah, MD Varun Shah, MD (PRINCIPAL_INVESTIGATOR) |
| University of Texas Southwestern | Dallas | Texas | 75235 | Muhanned Abu-Hijleh, MD Muhanned Abu-Hijleh, MD (PRINCIPAL_INVESTIGATOR) |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | Priya Patel, MD Priya Patel, MD (PRINCIPAL_INVESTIGATOR) |
| Medical College of Wisconsin (MCW) | Milwaukee | Wisconsin | 53226 | Jonathan Kurman, MD Jonathan Kurman, MD (PRINCIPAL_INVESTIGATOR) |
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