MedDataX Logo

Exalenz Lab Mode System Compared to Biopsy for H.Pylori Detection

NCT ID: NCT02528721

Last Updated: 2022-12-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

282 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The Exalenz Dual Mode BreathID® Hp System comprised of IDkit: Hp™ TWO and the Dual Mode BreathID® Hp test device will be used to perform a urea breath test in the initial diagnosis and post treatment monitoring of H.pylori infection in adult patients and its results will be compared to biopsy results.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients undergoing esophagogastroduodenoscopy (EGD) for initial diagnosis of H.pylori infection or post therapy confirmation of eradication will be eligible to participate in the trial. Two sets of biopsies will be taken: one set for histological analysis and one set for rapid urease test (RUT) analysis. The two results will be used as a gold standard composite score in determining the presence of H.pylori bacteria in the stomach. The Urea Breath Test (UBT) using the Exalenz Dual Mode BreathID Hp System will also be performed within a week of the biopsy. The outcome of the UBT will be compared to composite score of the biopsy and the accuracy of the UBT will be evaluated. The UBT will be performed using breath collection bags, where the subject will be asked to breathe into the bags before and after ingestion of the 13C-labelled urea.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Helicobacter Pylori Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Initial Diagnosis Subjects

Patients with clinical indication for H.pylori infection

Group Type EXPERIMENTAL

Dual Mode BreathID Hp System

Intervention Type DEVICE

The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device

Post Therapy Subjects

Patients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months

Group Type EXPERIMENTAL

Dual Mode BreathID Hp System

Intervention Type DEVICE

The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dual Mode BreathID Hp System

The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Hp™ TWO Dual Mode BreathID® Hp

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Be at least 18 years of age.
* Have the ability and willingness to sign the Informed Consent Form.
* Present with clinical indication of H. pylori and a candidate for upper endoscopy

For Initial Diagnosis arm:

• Symptomatic patients naïve to H.pylori treatment in the past 18 months

For Post-Therapy arm:

* Documented biopsy with positive outcome prior to eradication therapy (including method of determination)
* Documented eradication therapy within the past 6 months and completed at least 6 weeks prior to UBT

Exclusion Criteria

* Participation in other interventional trials.

* Antibiotics and/or Bismuth preparations within four (4) weeks prior to breath test.
* PPI or H2 blockers within two (2) weeks prior to breath test.
* Pregnant or breastfeeding women.
* Allergy to test substrates.
* Patient did not fast for the hour prior to the UBT
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Meridian Bioscience, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Del Sol Research Management

Tucson, Arizona, United States

Site Status

Ventura Clinical Trials

Ventura, California, United States

Site Status

Innovative Clincal Research

Lafayette, Colorado, United States

Site Status

Palmetto Research

Hialeah, Florida, United States

Site Status

Hope Clinical Research

Kissimmee, Florida, United States

Site Status

Metropolitan Gastro Group

Chevy Chase, Maryland, United States

Site Status

Gasrtrenetrology Associates of Western Michigan, West Michigan Clinical Research Center

Wyoming, Michigan, United States

Site Status

Digestive Disease Care

New Hyde Park, New York, United States

Site Status

Great Lakes Medical Research

Willoughby, Ohio, United States

Site Status

Innovative Clinical Research

Rapid City, South Dakota, United States

Site Status

Digestive Disease Center of South Texas, P.L.L.C

San Antonio, Texas, United States

Site Status

Barzilai Medical center

Ashkelon, , Israel

Site Status

Assaf Harofe Medical Center

Tzrifin, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Israel

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DM2-HP-0715

Identifier Type: -

Identifier Source: org_study_id