Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-01-11 @ 10:03 PM
Study NCT ID:
NCT01847820
Status:
TERMINATED
Last Update Posted:
2016-07-14
First Post:
2013-05-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of the AmniSure ROM Test
Sponsor:
QIAGEN Gaithersburg, Inc
Organization:
Study Overview
Official Title:
Clinical Evaluation of the AmniSure ROM Test
Status:
TERMINATED
Status Verified Date:
2016-07
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:
To show that having less qualified personnel (non-Laboratory trained professionals) perform the test yields the same result as if a Laboratory trained professional performed the test.
Detailed Description:
The main goal of this study is to show that when performed by less qualified personnel, the AmniSure® ROM Test is so simple and accurate that the likelihood of erroneous results by the Intended-User is negligible and that the test poses no unreasonable risk of harm to the patient if performed incorrectly.
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?: