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

Hillel Yaffe Medical Center

Status: Unknown

Conditions: Helicobacter Pylori

Treatments: Diagnostic Test: Fluorescent-labeled Urease Inhibitor Marker to Detect Helicobacter Pylori

Study type: Interventional

Funder types: Other

Identifiers

NCT04937426

HYMC-0085-20

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing gastroendoscopy with suspected Helicobacter Pylori

Exclusion criteria

• Patients with active bleeding
• Patients treated with anti-coagulation medication

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

200 participants in 1 patient group

Fluorescent-labeled Urease Inhibitor Marker to Detect Helicobacter Pylori

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Fluorescent-labeled Urease Inhibitor Marker to Detect Helicobacter Pylori