Ignite Creation Date:
2024-05-06 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03631472
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-05-09
First Post:
2018-08-13
Brief Title:
Gala Early Feasibility Study of RheOx
Sponsor:
Gala Therapeutics Inc
Organization:
Gala Therapeutics Inc
Study Overview
Official Title:
A Feasibility Study A Safety Evaluation of RheOx on Patients With Chronic Bronchitis in the United States
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Gala_EFS
Brief Summary:
An early feasibility study EFS to assess the safety and clinical utility of RheOx on patients with chronic bronchitis in the United States
Detailed Description:
RheOx is a device-based energy delivery system that delivers energy for the ablation of soft tissue such as the airway epithelium and sub-mucosal tissue layers The energy is delivered via a proprietary catheter through the bronchoscope
Two sessions of treatment will be delivered one month apart The right lung is treated at the first treatment session and the left lung is treated at the second treatment session approximately one month after the right side is treated Treatment will be delivered by a respiratory physician interventional pulmonologist in a tertiary teaching hospital during a bronchoscopic procedure The bronchoscopy will be delivered during general anesthesia It is anticipated that the bronchoscopic procedure will last less than 60 minutes in total Treatment will be deemed to have been delivered following the successful treatment during the two bronchoscopies
Subjects will be required to submit tests during the study including three CT scans lung respiratory function tests exercise testing
Two sessions of treatment will be delivered one month apart The right lung is treated at the first treatment session and the left lung is treated at the second treatment session approximately one month after the right side is treated Treatment will be delivered by a respiratory physician interventional pulmonologist in a tertiary teaching hospital during a bronchoscopic procedure The bronchoscopy will be delivered during general anesthesia It is anticipated that the bronchoscopic procedure will last less than 60 minutes in total Treatment will be deemed to have been delivered following the successful treatment during the two bronchoscopies
Subjects will be required to submit tests during the study including three CT scans lung respiratory function tests exercise testing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None