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The Performance of the APPY1 Test in the Evaluation of Possible Acute Appendicitis

NCT01652170 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2201

Last updated 2014-03-24

No results posted yet for this study

Summary

This study will consist of a brief interaction with the subject or parent or guardian to obtain consent, collect a blood sample, medical history, and physical examination of those who meet the inclusion criteria. The blood sample will be tested for the WBC value, as well as processed into plasma in order to compute the APPY1 Test result, which is based on a combination of the WBC value and the plasma MRP 8/14 and CRP concentrations received from the APPY1 Test cassette. There will be a 2-week (14 days +/- 3) follow-up telephone call for those subjects that were discharged from the ED without an appendectomy or diagnosis of acute appendicitis. Use of the APPY1 Test to help identify low risk patients could significantly reduce the use of CT scans in diagnosis of AA, thereby reducing the exposure to ionizing radiation in children, adolescents, and young adults.

Conditions

  • Acute Appendicitis

Sponsors & Collaborators

  • Venaxis, Inc.

    lead INDUSTRY

Principal Investigators

  • Dave Huckins, MD · Newton-Wellesley Hospital

Eligibility

Min Age
2 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01652170 on ClinicalTrials.gov