Ignite Creation Date:
2024-05-06 @ 1:05 AM
Last Modification Date:
2024-10-26 @ 10:58 AM
Study NCT ID:
NCT01720680
Status:
COMPLETED
Last Update Posted:
2013-06-28
First Post:
2012-10-25
Brief Title:
Prospective Exploratory Study to Assess the Effects of the AlphaCore Device in Patients With COPD
Sponsor:
University Hospital Antwerp
Organization:
University Hospital Antwerp
Study Overview
Official Title:
Open-label Prospective Exploratory Study to Assess the Effects of the AlphaCore Device on Central and Peripheral Airway Dimensions in Patients With COPD
Status:
COMPLETED
Status Verified Date:
2013-06
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:
None
Brief Summary:
Title Open-label prospective exploratory study to assess the effects of the AlphaCore device on central and peripheral airway dimensions in patients with COPD
Indication COPD patients
Study Design Open-label prospective design
Study Phase II
Test treatment duration 1 day
Test treatment AlphaCore device
Dosage regimen 1 session of stimulation during 90 seconds
Patient number up to 10 evaluable patients with COPD
Patient age 18 years
Sex male or female
Primary objective The evaluation of the effect of the AlphaCore device on central and peripheral airway dimensions with Computational Fluid Dynamics CFD
Secondary objectives The assessment of the effect of the AlphaCore device on lung function spirometry diffusion and resistance and on patient reported outcomes PROs
Indication COPD patients
Study Design Open-label prospective design
Study Phase II
Test treatment duration 1 day
Test treatment AlphaCore device
Dosage regimen 1 session of stimulation during 90 seconds
Patient number up to 10 evaluable patients with COPD
Patient age 18 years
Sex male or female
Primary objective The evaluation of the effect of the AlphaCore device on central and peripheral airway dimensions with Computational Fluid Dynamics CFD
Secondary objectives The assessment of the effect of the AlphaCore device on lung function spirometry diffusion and resistance and on patient reported outcomes PROs
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None