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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03060746
Other study ID # PRE-TREAT A001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 14, 2017
Est. completion date May 3, 2018

Study information

Verified date February 2019
Source DiaSorin Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary objective is to obtain stool samples from pre-therapy subjects already undergoing evaluation for an H. pylori infection by upper esophagogastroduodenoscopy (EGD) and gastric biopsy.


Description:

Stools will be collected and tested, at a later date, in a clinical performance study with an investigational H. pylori antigen assay. This study will be coordinated by the Sponsor.


Recruitment information / eligibility

Status Completed
Enrollment 277
Est. completion date May 3, 2018
Est. primary completion date May 3, 2018
Accepts healthy volunteers No
Gender All
Age group 22 Years and older
Eligibility Inclusion Criteria: - Adult = 22 years, either gender - Subject is symptomatic showing signs and symptoms of gastritis - Subject is not under evaluation for post-therapy follow up diagnosis - Subject is already undergoing upper EGD and obtaining a gastric biopsy as part of routine care for H. pylori diagnosing - Biopsy is obtained from antrum and/or corpus and is tested by CRM - At least two of the three CRM tests are performed - Subject whose EGD with biopsy procedure occurred = 7 days prior to stool collection - Willing and able to sign the IRB approved Informed Consent form for this project, or able to provide Informed Consent in accordance with 21 CFR 50 Subpart B Exclusion Criteria: - Any subject that does not meet the inclusion criteria - Subject with current severe H. pylori infection - Subject ingested compounds that may interfere with detection of H. pylori e.g. 4 weeks for all antibiotics, 2 weeks for Bismuth preparations or proton pump inhibitors prior to EGD/collection - Subject recently tested, less than 3 months and knowledge of H. pylori absence - Subject tested, less than one year and knowledge of H. pylori presence but NOT undergone prescribed treatment - Pregnant or lactating - Inability or unwilling to perform required study procedures - Subject is unable or unwilling to provide informed consent

Study Design


Intervention

Other:
Newly Diagnosed
Gastric biopsy tested by composite reference method (CRM) (histology, urease, culture) and stool sample

Locations

Country Name City State
Italy One (1) Location in Bologna, Italy Bologna
United States One (1) Location in North Carolina Asheville North Carolina
United States One (1) Location in Virginia Chesapeake Virginia
United States One (1) Location in Great Neck, New York Great Neck New York
United States One (1) Location in Greenville, South Carolina Greenville South Carolina
United States One (1) Location in Houston, Texas Houston Texas
United States One (1) Location in Ohio Mentor Ohio
United States One (1) Location in Arizonia Mesa Arizona
United States One (1) Location in Mission Hills, California Mission Hills California
United States One (1) Location in Oxnard, California Oxnard California
United States One (1) Location in Florida Palm Harbor Florida
United States One (1) Location in Missouri Saint Louis Missouri

Sponsors (2)

Lead Sponsor Collaborator
DiaSorin Inc. ICON Clinical Research

Countries where clinical trial is conducted

United States,  Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Helicobacter pylori Stool Collection In vitro diagnostic (IVD) device performance Through Study Completion, an average of 1 year
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