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

NCT ID: NCT01652170

Last Updated: 2014-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2201 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Appendicitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 2 to 20 years old (up until the 21st birthday),
* Right lower quadrant or poorly localized abdominal pain, or tenderness that includes the right lower quadrant, and/or other features including, but not limited to, nausea, vomiting, and/or anorexia, requiring acute appendicitis to be added to the differential,
* Onset of abdominal pain within 72 hours or less,
* Patients of either gender may participate and,
* Patient or accompanying parent or guardian is able to provide informed consent.

Exclusion Criteria

* History includes prior appendectomy,
* Subjects whose presentation history and physical examination place them at such high risk of acute appendicitis that it would be clinically reasonable to proceed with exploratory laparotomy and/or appendectomy without advanced imaging,
* Treatment with any immunosuppressive medication or chemotherapeutic agents within 28 days, or systemic steroids (oral or intravenous) within 14 days,
* History of end-stage, metastatic cancer or an active immune disorder,
* History includes abdominal trauma or invasive abdominal procedures/surgery within the previous two weeks,
* Patients who have received diagnostic imaging (CT, MRI, or US) for abdominal pain in the previous two weeks,
* Patients with report of abdominal pain greater than 72 hours,
* History of active bleeding disorder, which may complicate phlebotomy or placement of peripheral IV catheter,
* Participation in a research study within the previous 30 days,
* Prisoners of an adult or juvenile detention center, and
* Subject, parent or guardian unable to provide informed consent.
Minimum Eligible Age

2 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Venaxis, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dave Huckins, MD

Role: PRINCIPAL_INVESTIGATOR

Newton-Wellesley Hospital

Locations

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Phoenix Children's Hosptial

Phoenix, Arizona, United States

Site Status

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Site Status

UC Davis

Sacramento, California, United States

Site Status

Children's National Medical Center

Washington D.C., District of Columbia, United States

Site Status

University of Florida, College of Medicine

Jacksonville, Florida, United States

Site Status

All Children's Hospital

St. Petersburg, Florida, United States

Site Status

Emory-Egleston (CHOA)

Atlanta, Georgia, United States

Site Status

Scottish Rite (CHOA)

Atlanta, Georgia, United States

Site Status

Newton-Wellesley Hospital

Newton, Massachusetts, United States

Site Status

Baystate Medical Center

Springfield, Massachusetts, United States

Site Status

South Shore Hospital

Weymouth, Massachusetts, United States

Site Status

University of Michigan, Mott Children's Hospital

Ann Arbor, Michigan, United States

Site Status

Spectrum Health System

Grand Rapids, Michigan, United States

Site Status

The Children's Mercy Hosptial

Kansas City, Missouri, United States

Site Status

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Staten Island University Hospital

Staten Island, New York, United States

Site Status

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States

Site Status

Cincinnati Children's Hospital

Cincinnati, Ohio, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Nationwide Children's

Columbus, Ohio, United States

Site Status

OHSU

Portland, Oregon, United States

Site Status

Children's Hospital of Pittsburg

Pittsburgh, Pennsylvania, United States

Site Status

Rhode Island Hospital - Hasbro

Providence, Rhode Island, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Vanderbilt Children's Hospital

Nashville, Tennessee, United States

Site Status

Dell Children's Medical Center

Austin, Texas, United States

Site Status

St. Joseph's Regional Health Center

Bryan, Texas, United States

Site Status

St. Joseph's Emergency Center

College Station, Texas, United States

Site Status

Dallas Children's Hospital

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CP12-001

Identifier Type: -

Identifier Source: org_study_id

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