Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-25 @ 12:20 PM
Study NCT ID:
NCT04465461
Status:
COMPLETED
Last Update Posted:
2025-04-29
First Post:
2020-07-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Video Assisted Thoracic Surgery (VATS) Fissure Completion Prior to Zephyr® Endobronchial Valve Insertion
Sponsor:
Pulmonx Corporation
Organization:
Study Overview
Official Title:
A Pilot Study of Video Assisted Thoracic Surgery (VATS) Fissure Completion Prior to Zephyr® Endobronchial Valve Insertion for Severe Chronic Obstructive Pulmonary Disease (COPD) in Patients With COllateral VEntilation
Status:
COMPLETED
Status Verified Date:
2025-04
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:
COVE
Brief Summary:
Prospective, multi-centre, pilot study aimed to evaluate the effect of Video Assisted Thoracic Surgery (VATS) fissure completion on the efficacy of endobronchial valve insertion (Zephyr Valve) in the treatment of subjects with severe Chronic Obstructive Pulmonary Disease (COPD) who exhibit collateral ventilation.
Detailed Description:
The study will be a prospective, multi-centre, pilot study aimed to evaluate the effect of VATS fissure completion on the efficacy of endobronchial valve insertion (Zephyr Valve) in the treatment of subjects with severe COPD who exhibit collateral ventilation.
Study patients who provide informed consent and meet the initial inclusion/exclusion criteria following baseline screening assessments and multidisciplinary review to determine eligibility will undergo two procedures, not less than 28 days apart. The first procedure will involve an initial bronchoscopy and Chartis® assessment of collateral ventilation under general anaesthesia followed by a VATS fissure completion between targeted lobes in subjects that have collateral ventilation. The second procedure undertaken following fissure completion surgery will involve bronchoscopic insertion of Zephyr® Valve(s) in the targeted lobe, under sedation or general anaesthesia.
Subjects will be followed up over a 6-month period following VATS fissure completion and Zephyr® Endobronchial Valve (Zephyr Valve) insertion.
Study patients who provide informed consent and meet the initial inclusion/exclusion criteria following baseline screening assessments and multidisciplinary review to determine eligibility will undergo two procedures, not less than 28 days apart. The first procedure will involve an initial bronchoscopy and Chartis® assessment of collateral ventilation under general anaesthesia followed by a VATS fissure completion between targeted lobes in subjects that have collateral ventilation. The second procedure undertaken following fissure completion surgery will involve bronchoscopic insertion of Zephyr® Valve(s) in the targeted lobe, under sedation or general anaesthesia.
Subjects will be followed up over a 6-month period following VATS fissure completion and Zephyr® Endobronchial Valve (Zephyr Valve) insertion.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: