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Completed No phase listed Observational

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

ClinicalTrials.gov ID: NCT01652170

Public ClinicalTrials.gov record NCT01652170. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 4, 2026, 9:18 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01652170
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
Venaxis, Inc.
Industry
Enrollment
2,201 participants

Conditions and interventions

Interventions

Not listed

Eligibility (public fields only)

Age range
2 Years to 20 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 31, 2012
Primary completion
Jan 31, 2014
Completion
Jan 31, 2014
Last update posted
Mar 23, 2014

2013 – 2014

United States locations

U.S. sites
29
U.S. states
19
U.S. cities
28
Facility City State ZIP Site status
Phoenix Children's Hosptial Phoenix Arizona 85016
Arkansas Children's Hospital Little Rock Arkansas 72202
UC Davis Sacramento California 95817
Children's National Medical Center Washington D.C. District of Columbia 20010
University of Florida, College of Medicine Jacksonville Florida 32209
All Children's Hospital St. Petersburg Florida 33701
Emory-Egleston (CHOA) Atlanta Georgia 30322
Scottish Rite (CHOA) Atlanta Georgia 30342
Newton-Wellesley Hospital Newton Massachusetts 02462
Baystate Medical Center Springfield Massachusetts 01199
South Shore Hospital Weymouth Massachusetts 02190
University of Michigan, Mott Children's Hospital Ann Arbor Michigan 48109
Spectrum Health System Grand Rapids Michigan 49503
The Children's Mercy Hosptial Kansas City Missouri 64108
Dartmouth Hitchcock Medical Center Lebanon New Hampshire 03766
Staten Island University Hospital Staten Island New York 10305
Wake Forest Baptist Health Winston-Salem North Carolina 27175
Cincinnati Children's Hospital Cincinnati Ohio 45229
Cleveland Clinic Cleveland Ohio 44495
Nationwide Children's Columbus Ohio 43205
OHSU Portland Oregon 97239
Children's Hospital of Pittsburg Pittsburgh Pennsylvania 15224
Rhode Island Hospital - Hasbro Providence Rhode Island 02903
Medical University of South Carolina Charleston South Carolina 29425
Vanderbilt Children's Hospital Nashville Tennessee 37232
Dell Children's Medical Center Austin Texas 78723
St. Joseph's Regional Health Center Bryan Texas 77802
St. Joseph's Emergency Center College Station Texas 77845
Dallas Children's Hospital Dallas Texas 75235

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01652170, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 23, 2014 · Synced Sep 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01652170 live on ClinicalTrials.gov.

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