NCT01652170

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

The Performance of the APPY1 Test in the Evaluation of Possible Acute Appendicitis in Children, Adolescents, and Young Adults Presenting to the Emergency Department

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,201 (actual)
• Sponsor: Venaxis, Inc. · Industry
• Sex: All
• Age: 2 Years – 20 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2012-07-27
• Last updated: 2014-03-24

Locations

29 sites across 1 country: United States