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Bag Mode BreathID Hp Validation Versus Endoscopy in Detection of Helicobacter Pylori

NCT02010112 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 193

Last updated 2022-12-20

No results posted yet for this study

Summary

A new method of breath collection for testing for Helicobacter Pylori infection has been developed by Exalenz. In this study, it will be compared to the gold standard- endoscopy results to prove its accuracy.

Conditions

  • Helicobacter Pylori Infection

Interventions

OTHER

Breath Test Collection bags

Breath Collection bags will be used to collect breath of subjects before and after ingestion of 13-C breath test substrate

Sponsors & Collaborators

  • Meridian Bioscience, Inc.

    lead INDUSTRY

Principal Investigators

  • Melina Arazy, M.D. · VP of clinical affairs, Exalenz

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02010112 on ClinicalTrials.gov