The Performance of the APPY1 Test in the Evaluation of Possible Acute Appendicitis
NCT ID: NCT01652170
Last Updated: 2014-03-24
Study Results
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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COMPLETED
2201 participants
OBSERVATIONAL
2013-01-31
2014-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
2 Years
20 Years
ALL
No
Sponsors
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Venaxis, Inc.
INDUSTRY
Responsible Party
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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
Arkansas Children's Hospital
Little Rock, Arkansas, United States
UC Davis
Sacramento, California, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
University of Florida, College of Medicine
Jacksonville, Florida, United States
All Children's Hospital
St. Petersburg, Florida, United States
Emory-Egleston (CHOA)
Atlanta, Georgia, United States
Scottish Rite (CHOA)
Atlanta, Georgia, United States
Newton-Wellesley Hospital
Newton, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
South Shore Hospital
Weymouth, Massachusetts, United States
University of Michigan, Mott Children's Hospital
Ann Arbor, Michigan, United States
Spectrum Health System
Grand Rapids, Michigan, United States
The Children's Mercy Hosptial
Kansas City, Missouri, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Staten Island University Hospital
Staten Island, New York, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Nationwide Children's
Columbus, Ohio, United States
OHSU
Portland, Oregon, United States
Children's Hospital of Pittsburg
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital - Hasbro
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt Children's Hospital
Nashville, Tennessee, United States
Dell Children's Medical Center
Austin, Texas, United States
St. Joseph's Regional Health Center
Bryan, Texas, United States
St. Joseph's Emergency Center
College Station, Texas, United States
Dallas Children's Hospital
Dallas, Texas, United States
Countries
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Other Identifiers
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CP12-001
Identifier Type: -
Identifier Source: org_study_id
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