Helicobacter Pylori InfectionNCT05349578
Gastric Swab for Helicobacter Pylori Detection
A study testing swab RUT in people with Helicobacter Pylori Infection, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
A randomized controlled trial for comparing the Helicobacter pylori test using the swap method and the method using the conventional biopsy. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- swab RUT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2021to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 20-80
- Patients who undergo esophagogastroduodenoscopy and need for investigation of Helicobacter pylori infection.
Who cannot join
- Surgical history of any kind of gastrectomy
- Patients with contraindication of esophagogastroduodenoscopy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Comparison of Cotton Swab Method and Conventional Biopsy Sampling in Rapid Urease Test 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.
Read the 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.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- swab RUT
- Keywords
- Helicobacter Pylori, rapid urease test, swab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
swab RUTDiagnostic test
rapid urease test using swab instead of biopsied tissue
| Study group | Role | What they receive |
|---|---|---|
| Tissue | Other | conventional RUT using biopsied tissue Receives: Diagnostic Test: swab RUT |
| Swab | Experimental | RUT using swab Receives: Diagnostic Test: swab RUT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy
Accuracy of diagnosis for Helicobacter pylori infection
Measured: the same day wtih EGD
Secondary outcomes (1)
sensitivity, false positive, false negative rate, etc.
Measured: the same day wtih EGD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start1 Mar 2021
- Primary completion31 Dec 2021
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyunsoo Chung, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05349578
- Sponsor's protocol ID
- 2108-016-1247
- Status last verified
- Apr 2022
- First submitted
- 21 Apr 2022
- Last updated
- 27 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37026561
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparison of Cotton Swab Method and Conventional Biopsy Sampling in Rapid Urease Test for Helicobacter Pylori Detection
- ClinicalTrials.gov ID
- NCT05349578
- Acronym / sponsor ID
- 2108-016-1247
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter Pylori, rapid urease test, swab
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tissue | Other | Diagnostic Test: swab RUTconventional RUT using biopsied tissue |
| Swab | Experimental | Diagnostic Test: swab RUTRUT using swab |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged 20-80
- Patients who undergo esophagogastroduodenoscopy and need for investigation of Helicobacter pylori infection.
Key exclusion criteria (2 listed)
- Surgical history of any kind of gastrectomy
- Patients with contraindication of esophagogastroduodenoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| swab RUTrapid urease test using swab instead of biopsied tissue | Diagnostic test | Swab, Tissue |
Primary outcome
Accuracy
Time frame: the same day wtih EGD
Accuracy of diagnosis for Helicobacter pylori infection
1 secondary outcome
sensitivity, false positive, false negative rate, etc.
Time frame: the same day wtih EGD
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Derived from this study: PubMed 37026561Soh 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing swab RUT in people with Helicobacter Pylori Infection, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy (time frame: the same day wtih EGD). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05349578, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.