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NCT04937426 Clinical Trial

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

Helicobacter Pylori Clinical Trial

Official title:
Development of a Laboratory Test for the Detection of a Fluorescent-labeled Urease Inhibitor Marker Attached to Helicobacter Pylori Using Biopsies Taken During Gastroscopy in Patients in Which the Bacterium is Suspected

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04937426
Other study ID # HYMC-0085-20
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 2021
Est. completion date July 2022

Study information
Verified date June 2021
Source Hillel Yaffe Medical Center
Contact Natalie Noam-Amar, MA
Phone 052-3132408
Email nataliea219@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date July 2022
Est. primary completion date July 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients undergoing gastroendoscopy with suspected Helicobacter Pylori Exclusion Criteria: - Patients with active bleeding - Patients treated with anti-coagulation medication

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Fluorescent-labeled Urease Inhibitor Marker to Detect Helicobacter Pylori
Diagnostic laboratory test for detection of helicobacter pylori

Locations
Country Name City State
Israel Hillel Yaffe Medical Center Hadera

Sponsors (1)
Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy of a Fluorescent-labeled Urease Inhibitor Marker to Detect Helicobacter Pylori Infection Comparison of results of biopsies analyzed with a fluorescent-labeled urease inhibitor marker to detect Helicobacter Pylori infection and results will be compared to standard tests to detect Helicobacter Pylori Two years
See also
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Recruiting NCT04029493 - The Situation of Re-infection of Helicobacter Pylori After Successful Eradication
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