Development of a Laboratory Test for the Detection of a Fluorescent-labeled Urease Inhibitor Marker Attached to Helicobacter Pylori

NCT ID: NCT04937426

Last Updated: 2021-06-24

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-31

Study Completion Date

2022-07-31

Brief Summary

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The aim of this study is to compare the usual rapid urease test (RUT) to a new florescent-labeled urease inhibitor marker to diagnose Helicobacter Pylori.

Detailed Description

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Conditions

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Helicobacter Pylori

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fluorescent-labeled Urease Inhibitor Marker to Detect Helicobacter Pylori

During gastroscopy additional biopsies are taken in cases where infection with helicobacter pylori is suspected. It will then undergo laboratory analysis with fluorescent-labeled urease inhibitor marker. Results will be compared to standard analysis to determine efficacy.

Group Type EXPERIMENTAL

Fluorescent-labeled Urease Inhibitor Marker to Detect Helicobacter Pylori

Intervention Type DIAGNOSTIC_TEST

Diagnostic laboratory test for detection of helicobacter pylori

Interventions

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Fluorescent-labeled Urease Inhibitor Marker to Detect Helicobacter Pylori

Diagnostic laboratory test for detection of helicobacter pylori

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing gastroendoscopy with suspected Helicobacter Pylori

Exclusion Criteria

* Patients with active bleeding
* Patients treated with anti-coagulation medication
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yael Kopelman, MD

Role: PRINCIPAL_INVESTIGATOR

Hillel Yaffe Medical Center

Locations

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Hillel Yaffe Medical Center

Hadera, , Israel

Site Status

Countries

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Israel

Central Contacts

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Natalie Noam-Amar, MA

Role: CONTACT

052-3132408

Facility Contacts

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Elisabeth Mahajna, MA

Role: primary

04-7744695

Other Identifiers

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HYMC-0085-20

Identifier Type: -

Identifier Source: org_study_id

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