NCT01803113

Brief Summary

The objective of this field study is to demonstrate the clinical performance of the Sofia hCG FIA Test, using urine specimens from females of childbearing age.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
975

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Shorter than P25 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2013

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2013

Completed
Last Updated

March 13, 2013

Status Verified

March 1, 2013

Enrollment Period

2 months

First QC Date

February 21, 2013

Last Update Submit

March 11, 2013

Conditions

Pregnancy, Early Detection

Keywords

PregnancyhCG

Outcome Measures

Primary Outcomes (1)

  • Determination of presence of hCG in urine

    Clinical performance will be based on comparison of Sofia hCG FIA test results to those obtained from an FDA-cleared hCG test.

    1 day

Interventions

Sofia hCG FIADEVICE

Qualitative detection via immunofluorescence technology of increased level of hCG present in urine.

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any female of childbearing potential being screened for pregnancy

You may qualify if:

  • Female subjects of childbearing age, who are being screened for pregnancy and who have signed the informed consent

You may not qualify if:

  • Subject is post-menopausal.
  • Subject within the past six weeks has experienced any of the following: delivered a newborn; had an abortion or a natural termination (miscarriage); or, received hCG supplements.
  • Subject has had a hysterectomy.
  • Unable to understand and consent to participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Jose Castaneda, MD

Boynton Beach, Florida, 33435-7959, United States

Location

NECCR of Massachusetts, LLC

Fall River, Massachusetts, 02720, United States

Location

New England Center for Clinical Research Fall River,LLC (NECCR)

Fall River, Massachusetts, 02720, United States

Location

Partners In Obstetrics and Gynecology, Inc.

Pawtucket, Rhode Island, 02860, United States

Location

Planned Parenthood Gulf Coast

Houston, Texas, 77023, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Leftover urine specimens may be retained to be used for further product testing.

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2013

First Posted

March 4, 2013

Study Start

January 1, 2013

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

March 13, 2013

Record last verified: 2013-03

Locations

US(5)