Gastric Swab for Helicobacter Pylori Detection | NCT05349578

Studies
Gastric Swab for Helicobacter Pylori Detection

NCT05349578

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Apr 27, 2022Actual

Enrollment

69Actual

Phase

Not Applicable

Conditions

Helicobacter Pylori Infection

Interventions

swab RUT

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2021Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Mar 1, 2022Actual

First Submitted Date

Apr 21, 2022

First Submission Date that Met QC Criteria

Apr 21, 2022

First Posted Date

Apr 27, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2022

Last Update Posted Date

Apr 27, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hyunsoo Chung, Associate Professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

69Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tissue	Other	conventional RUT using biopsied tissue	Diagnostic Test: swab RUT
Swab	Experimental	RUT using swab	Diagnostic Test: swab RUT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
swab RUT	Diagnostic Test	rapid urease test using swab instead of biopsied tissue	Swab Tissue

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University		Seoul		03080	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37026561	Derived	Soh H, Kim N, Moon J, Lee HM, Kim B, Cho SJ, Kim SG, Chung H. Gastric mucosal swab as an alternative to biopsy for Helicobacter pylori detection. Helicobacter. 2023 Jun;28(3):e12980. doi: 10.1111/hel.12980. Epub 2023 Apr 7.