Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT04469218
Status:
COMPLETED
Last Update Posted:
2024-01-16
First Post:
2020-07-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Clinical Trial Using a New Medical Device to Evaluate Its Impact on IV Care and Clinical Complications
Sponsor:
Lineus Medical
Organization:
Study Overview
Official Title:
Dislodgement Infiltration Phlebitis Prevention Eliminating Restarts (DIPPER)
Status:
COMPLETED
Status Verified Date:
2023-12
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:
DIPPER
Brief Summary:
A clinical trial comparing two groups of patients that are randomized into one group having SafeBreak Vascular attached to their peripheral IV lines and a second control group that receives the current standard of care (no SafeBreak Vascular) to determine SafeBreak Vascular's impact on IV clinical care and complications.
Detailed Description:
This randomized clinical trial's goal is to determine SafeBreak Vascular's impact, a break-away connector that separates when a harmful force is placed on a peripheral IV line, on IV clinical care and complications.
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?: