Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2025-12-31 @ 8:34 AM
Study NCT ID:
NCT00768495
Status:
UNKNOWN
Last Update Posted:
2009-06-04
First Post:
2008-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hyperspectral Imaging Pre and Post Endovascular Intervention
Sponsor:
HyperMed
Organization:
Study Overview
Official Title:
Evaluation of the Success of Endovascular Peripheral Revascularization for the Treatment of Chronic Limb Ischemia by Measuring OxyHb and DeoxyHb Using a New Hyperspectral Imaging Device (OxyVu).
Status:
UNKNOWN
Status Verified Date:
2009-06
Last Known Status:
RECRUITING
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:
CLI-Pre/Post
Brief Summary:
This trial will collect tissue oxygenation data via hyperspectral imaging before and after endovascular procedures.
Detailed Description:
This will be a nonrandomized, nonblinded, prospective observational study to correlate the results obtained with the traditional measures of success of endovascular revascularization of peripheral arteries for the treatment of chronic limb ischemia; i.e., ABPI, PVR with oxyhemoglobin (OxyHb) and deoxyhemoglobin (DeoxyHb) measurements obtained with a new imaging device manufactured by HyperMed Inc (OxyVu) that uses hyperspectral technology.
Study Oversight
Has Oversight DMC:
False
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?: