Gastric Swab for Helicobacter Pylori Detection

A Prospective Comparison of Cotton Swab Method and Conventional Biopsy Sampling in Rapid Urease Test for Helicobacter Pylori Detection

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05349578

Enrollment

Registered

2022-04-27

Start date

2021-03-01

Completion date

2022-03-01

Last updated

2022-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter Pylori, rapid urease test, swab

Brief summary

A randomized controlled trial for comparing the Helicobacter pylori test using the swap method and the method using the conventional biopsy.

Detailed description

The aim of this study is to conduct a prospective study under the hypothesis that a cotton swab method in the rapid urease test is not inferior to the conventional biopsy.

Interventions

DIAGNOSTIC_TESTswab RUT

rapid urease test using swab instead of biopsied tissue

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Adults aged 20-80 * Patients who undergo esophagogastroduodenoscopy and need for investigation of Helicobacter pylori infection.

Exclusion criteria

* Surgical history of any kind of gastrectomy * Patients with contraindication of esophagogastroduodenoscopy

Design outcomes

Primary

Measure	Time frame	Description
Accuracy	the same day wtih EGD	Accuracy of diagnosis for Helicobacter pylori infection

Secondary

Measure	Time frame
sensitivity, false positive, false negative rate, etc.	the same day wtih EGD

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026