Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-03-05 @ 4:11 AM
Study NCT ID:
NCT03109405
Status:
COMPLETED
Last Update Posted:
2018-04-05
First Post:
2016-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assess Veinplicity Venous Access Device Safety and Effectiveness
Sponsor:
Physeon GmbH
Organization:
Study Overview
Official Title:
A Prospective, Single Center, Randomized, Cross-over Clinical Trial to Assess the Safety and Effectiveness of the Veinplicity Venous Access Device
Status:
COMPLETED
Status Verified Date:
2018-04
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 was to examine the Veinplicity Device as an adjunctive IV cannulation tool in subjects with a history of difficult to access veins. The Veinplicity Device is intended to improve venous access rates in compromised patients by taking advantage of the increased circulation that results from provoked muscle stimulation. The study collected information about the device, intravenous access, user and patient perceptions for IV access, and any device or procedural complications or other adverse events. Device use was examined with patients in both a prone and upright position.
Detailed Description:
None
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?: