Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:29 PM
Study NCT ID:
NCT01476293
Status:
COMPLETED
Last Update Posted:
2012-02-20
First Post:
2011-11-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Monitoring the Peripheral Intravenous Infusion Site for Infiltration and Extravasation
Sponsor:
ivWatch, LLC
Organization:
Study Overview
Official Title:
Non-invasive Optical Medical Device for Monitoring and Detecting Peripheral Intravenous Infusion Sites for Infiltration and Extravasation in Subjects Receiving Continuous Fluids
Status:
COMPLETED
Status Verified Date:
2011-11
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:
The purpose of this study to to monitor the peripheral intravenous (PIV) site on subjects receiving continuous IV fluids for infiltration and extravasation events. Infiltration is an indication that the PIV is leaking fluids outside of the vascular system. The study hypothesis is to demonstrate that changes in the optical signals of the non-invasive monitoring medical device will detect infiltration and extravasation events.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: