Development of a Laboratory Test for the Detection of a Fluorescent-labeled Urease Inhibitor Marker Attached to Helicobacter Pylori
Sponsor
Hillel Yaffe Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04937426
Collaborator
(none)
200
1
1
12
16.7
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date
:
Jul 1, 2021
Anticipated Primary Completion Date
:
Jul 1, 2022
Anticipated Study Completion Date
:
Jul 1, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Diagnostic Test: Fluorescent-labeled Urease Inhibitor Marker to Detect Helicobacter Pylori
Diagnostic laboratory test for detection of helicobacter pylori
|
Outcome Measures
Primary Outcome Measures
- Efficacy of a Fluorescent-labeled Urease Inhibitor Marker to Detect Helicobacter Pylori Infection [Two years]
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
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patients undergoing gastroendoscopy with suspected Helicobacter Pylori
Exclusion Criteria:
-
Patients with active bleeding
-
Patients treated with anti-coagulation medication
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hillel Yaffe Medical Center | Hadera | Israel | 38100 |
Sponsors and Collaborators
- Hillel Yaffe Medical Center
Investigators
- Principal Investigator: Yael Kopelman, MD, Hillel Yaffe Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT04937426
Other Study ID Numbers:
- HYMC-0085-20
First Posted:
Jun 24, 2021
Last Update Posted:
Jun 24, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No