Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2026-01-11 @ 6:29 AM
Study NCT ID:
NCT04263532
Status:
TERMINATED
Last Update Posted:
2025-05-09
First Post:
2020-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vector Efficacy Cross-Over Pilot Study
Sponsor:
Philips Clinical & Medical Affairs Global
Organization:
Study Overview
Official Title:
Randomized Controlled Cross-Over Pilot Study of the Effectiveness of the Vector NIV Device in Hypercapnic COPD Patients With Expiratory Flow Limitation
Status:
TERMINATED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study discontinued due to shifted business priorities.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study evaluates the safety and efficacy of the modified Bi-level positive airway pressure (BiPAP) A40 with Vector Algorithm to treat Chronic Obstructive Pulmonary Disease (COPD) patients with excessive carbon dioxide in their bloodstream (hypercapnia) and expiratory flow limitation (EFL), a constriction of the lower airways. The study will include current users of non-invasive ventilation (NIV) as well as those who are not currently using an NIV device.
Detailed Description:
This study is a prospective randomized controlled cross-over pilot trial to investigate the clinical efficacy and safety of the Modified Bi-level positive airway pressure (BiPAP) A40 with Vector Algorithm (Vector Device), a non-invasive ventilation (NIV) device, to treat Chronic Obstructive Pulmonary Disease (COPD). Approximately 30 COPD patients with chronic hypercapnia and evidence of expiratory flow limitation (EFL) will be included. It is estimated that 50 patients may need to be enrolled in order to complete 30. There will be two different patient cohort groups, patients that are current users of NIV and patients that are Naïve to NIV. Only those that meet the inclusion/exclusion criteria will be screened to determine if EFL is present. If participants are found to have EFL they will undergo a 20 minute EFL abolishment determination. Those participants that have EFL and a titrated expiratory positive airway pressure (EPAP) ≥6cmH2O will be scheduled for study visit 2. During study visit 2, participants will be randomized in a 1:1 ratio to receive either standard NIV (control) or Vector (Active) for the first 4 to 6-week at-home treatment period, followed by the other treatment during the second 4 to 6 weeks. Participants will have up to 4 (NIV current Users) or 5 (NIV Naïve) in-person visits that will include 2 overnight sleep studies with polysomnogram (PSG).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: