Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-04-14 @ 11:17 AM
Study NCT ID:
NCT02378727
Status:
UNKNOWN
Last Update Posted:
2016-07-06
First Post:
2015-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CompuFlo® Assessment Study for the Epidural Space Verification
Sponsor:
Milestone Scientific, Inc
Organization:
Study Overview
Official Title:
CompuFlo® Assessment Study (COMPASS): A Randomized, Controlled, Parallel Group, Multicenter, Pivotal Study to Assess the Safety and Effectiveness of the Epidural Space Verification With the CompuFlo® Epidural Computer Controlled System
Status:
UNKNOWN
Status Verified Date:
2016-06
Last Known Status:
ACTIVE_NOT_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:
COMPASS
Brief Summary:
The purpose of this pivotal study is to demonstrate safety and effectiveness of the CompuFlo® Epidural Computer Controlled System (referred to hereafter as CompuFlo® Epidural) for the epidural space verification.
The CompuFlo® Epidural System is limited by federal law for investigational use only in United States of America and has received CE mark in European Union.
The CompuFlo® Epidural System is limited by federal law for investigational use only in United States of America and has received CE mark in European Union.
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?: