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Completed

NCT Number: NCT05349578

Gastric Swab for Helicobacter Pylori Detection

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

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Key information

Conditions

Helicobacter Pylori Infection

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

swab RUT

Diagnostic Test

rapid urease test using swab instead of biopsied tissue

Primary outcomes

  1. Accuracy

    Time frame: the same day wtih EGD

    Accuracy of diagnosis for Helicobacter pylori infection

Secondary outcomes

  1. sensitivity, false positive, false negative rate, etc.

    Time frame: the same day wtih EGD

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Apr 27, 2022
Registry last updated
Apr 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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