NCT04937426

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 24, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

June 24, 2021

Status Verified

June 1, 2021

Enrollment Period

1 year

First QC Date

June 16, 2021

Last Update Submit

June 16, 2021

Conditions

Helicobacter Pylori

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Fluorescent-labeled Urease Inhibitor Marker to Detect Helicobacter Pylori

EXPERIMENTAL

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

Interventions

Fluorescent-labeled Urease Inhibitor Marker to Detect Helicobacter PyloriDIAGNOSTIC_TEST

Diagnostic laboratory test for detection of helicobacter pylori

Fluorescent-labeled Urease Inhibitor Marker to Detect Helicobacter Pylori

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing gastroendoscopy with suspected Helicobacter Pylori

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

Study Officials

  • Yael Kopelman, MD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Natalie Noam-Amar, MA

CONTACT

052-3132408nataliea219@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2021

First Posted

June 24, 2021

Study Start

July 1, 2021

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

June 24, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)