Trials / Terminated
TerminatedNCT01847820
Clinical Evaluation of the AmniSure ROM Test
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 383 (actual)
- Sponsor
- QIAGEN Gaithersburg, Inc · Industry
- Sex
- Female
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AmniSure ROM test | Comparison of AmniSure ROM test to clinical diagnosis of ROM. |
Timeline
- Start date
- 2013-08-01
- Primary completion
- 2016-07-01
- Completion
- 2016-07-01
- First posted
- 2013-05-07
- Last updated
- 2016-07-14
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01847820. Inclusion in this directory is not an endorsement.