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| Name | Class |
|---|---|
| Northwestern University | OTHER |
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The primary purpose of this observational study is to demonstrate the feasibility of an automated point-of-care urine diagnostic device in determining the pregnancy status of patients through urine samples collected from patients at Northwestern University. Our hypothesis is that this automated point-of-care urine diagnostic device will be able to accurately determine a patient's pregnancy status at least 95% of the time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant female | Patient has been determined pregnant with a urine pregnancy test and, if applicable, a serum pregnancy test performed at Northwestern University. |
| |
| Non-pregnant female | Patient has been determined not pregnant with a urine pregnancy test and, if applicable, a serum pregnancy test performed at Northwestern University. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregnancy test | Diagnostic Test | Detects hormone (hCG, Human Chorionic Gonadotropin) produced by the body during pregnancy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy in determining pregnancy status | Compare qualitative pregnancy test results generated by Voyant's device with urine pregnancy test result(s) and, if applicable, serum pregnancy test results performed at Northwestern University. From this comparison, we will determine the accuracy of Voyant's device. We will be using the same urine sample used at Northwestern. | Time of collection - 1 month post collection |
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Inclusion Criteria:
The following special population will be included:
Exclusion Criteria:
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Female patients of childbearing age
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Tu, MS, BS | Contact | 214-415-4288 | michael.tu@voyant.health | |
| Claire Y Zhou, BA | Contact | 949-355-3695 | claire.zhou@voyant.health |
| Name | Affiliation | Role |
|---|---|---|
| MaryEllen Pavone, MD, MSCI | Northwestern University, Department of Obstetrics and Gynecology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Recruiting | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D011258 | Pregnancy Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003944 | Diagnostic Techniques, Obstetrical and Gynecological |
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Urine
| D008919 | Investigative Techniques |