Ignite Creation Date:
2024-05-06 @ 3:05 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04514913
Status:
WITHDRAWN
Last Update Posted:
2023-02-21
First Post:
2020-08-12
Brief Title:
Study of Focal Airway Disease in Asthma Using Image Guided Bronchoscopy
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Study of Focal Airway Disease in Asthma Using Image Guided Bronchoscopy
Status:
WITHDRAWN
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The restrictions on research imposed for the COVID-19 pandemic prevented us from launching study recruitment and visits At this stage our funding is not sufficient to allow us to enroll sufficient numbers of patients so we will close the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOFA
Brief Summary:
This is a single center study of 60 subjects including those with asthma and mucus plugging those with asthma and without mucus plugging and healthy controls Screening data will be reviewed to determine participant eligibility Participants who meet all inclusion criteria will participate in image-guided bronchoscopy virtual navigation bronchoscopy VNB to sample airway biospecimens in mucus plugged and control airways
Detailed Description:
This is a single center study of 60 subjects The investigators will enroll 30 subjects with asthma who demonstrate mucus plugging on a screening CT lung scan 15 subjects with asthma without mucus plugging and 15 healthy controls The healthy controls and subjects with asthma but without mucus plugging with also undergo CT scans to confirm that their lungs arent obstructed by mucus
Screening data will be reviewed to determine participant eligibility Participants who meet all inclusion criteria will participate in image-guided bronchoscopy virtual navigation bronchoscopy VNB to sample airway biospecimens in mucus plugged and control airways Subjects will participate in up to 5 study visits at the Airway Clinical Research Center
Screening data will be reviewed to determine participant eligibility Participants who meet all inclusion criteria will participate in image-guided bronchoscopy virtual navigation bronchoscopy VNB to sample airway biospecimens in mucus plugged and control airways Subjects will participate in up to 5 study visits at the Airway Clinical Research Center
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2P01HL107202-06A1 | NIH | None | httpsreporternihgovquickSearch2P01HL107202-06A1 |