Helicobacter Pylori InfectionNCT03973242
Dual-focus Magnification With Narrow-band Imaging in Helicobacter Pylori Infection
A study testing Dual focus with narrow band imaging in people with Helicobacter Pylori Infection, run by Kyunghee University Medical Center at 1 site in South Korea.
Trial summary
Dual-focus with narrow-band imaging (DF-NBI) is a novel technique to improve the quality of images of the irregular mucosal structures and microvessels of gastric neoplasms. The investigators compare this technique with conventional white light (WL) endoscopy to predict Helicobacter pylori infection. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Dual focus with narrow band imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 292 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Mar 2018to 31 Mar 2020
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- consecutive patients who have undergone uper gastrointestinal endoscopy for diagnosis or screening of cancer.
Who cannot join
- Those whose Hp status had already been clarified
- Pregnancy
- History of partial gastrectomy
- Taking proton pump inhibitor, antithrombotics or antibiotics within 4 weeks
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kyung Hee University Hospital
Seoul, 130-872
Jae-Young Jang, MD, PhD, 82-2-958-8149
Jung-Wook Kim, M.D., Ph.D.
About this study
Official title: Usefulness of Dual-focus Magnification With Narrow-band Imaging in the Prediction of Helicobacter Pylori Infection: a Prospective Randomized Trial
Dual-focus with narrow-band imaging (DF-NBI) is a novel technique to improve the quality of images of the irregular mucosal structures and microvessels of gastric neoplasms. The investigators compare this technique with conventional white light (WL) endoscopy to predict Helicobacter pylori infection.
Read the detailed description
The subjects are patients who underwent upper gastrointestinal endoscopy under sedation. Participants are randomized into DF-NBI and WL groups. Rapid urease test will be performed in all cases. By captured images of gastric mucosa, classification of DF-NBI for Helicobacter pylori infected mucosa will be developed and validated. The established classification of WL for Helicobacter pylori infection will be used. Finally, the investigators will compare the accuracy between two groups based on each classification.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Dual focus with narrow band imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual focus with narrow band imagingDevice
dual focus mode for imaging magnification + narrow band imaging for the enhancement of mucosal vascularity and irregularity
| Study group | Role | What they receive |
|---|---|---|
| DF-NBI | Active comparator | Initially, gastric mucosa is observed by conventional wight light endoscopy. Then, converting to dual-focus mode with narrow band imaging is done. Gastric mucosa is observed once again by DF-NBI mode. Receives: Device: Dual focus with narrow band imaging |
| WL | Placebo comparator | Conventional white light endoscopy use It is routine practice for the upper gastrointestinal endoscopy. Receives: Device: Dual focus with narrow band imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accurate prediction of Helicobacter pylori status
Sensitivity, specificity, PPV, and NPV
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start15 Mar 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- 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
- Model description
- Study group: Dual Focus with Narrow band imaging Control group: White light endoscopy
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 292 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyunghee University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung-Wook Kim, Kyunghee University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973242
- Sponsor's protocol ID
- DFHP2018
- Status last verified
- May 2019
- First submitted
- 31 May 2019
- Last updated
- 4 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If needed, IPD will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Dual-focus Magnification With Narrow-band Imaging in the Prediction of Helicobacter Pylori Infection: a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT03973242
- Acronym / sponsor ID
- DFHP2018
- Conditions
- Helicobacter Pylori Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 292 participants (estimated)
- Lead sponsor
- Kyunghee University Medical CenterUniversity, hospital or other
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 4 Jun 2019 (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.
Dual-focus with narrow-band imaging (DF-NBI) is a novel technique to improve the quality of images of the irregular mucosal structures and microvessels of gastric neoplasms. The investigators compare this technique with conventional white light (WL) endoscopy to predict Helicobacter pylori infection.
Detailed description
The subjects are patients who underwent upper gastrointestinal endoscopy under sedation. Participants are randomized into DF-NBI and WL groups. Rapid urease test will be performed in all cases. By captured images of gastric mucosa, classification of DF-NBI for Helicobacter pylori infected mucosa will be developed and validated. The established classification of WL for Helicobacter pylori infection will be used. Finally, the investigators will compare the accuracy between two groups based on each classification.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Study group: Dual Focus with Narrow band imaging Control group: White light endoscopy
| Arm | Type | Receives |
|---|---|---|
| DF-NBI | Active comparator | Device: Dual focus with narrow band imagingInitially, gastric mucosa is observed by conventional wight light endoscopy. Then, converting to dual-focus mode with narrow band imaging is done. Gastric mucosa is observed once again by DF-NBI mode. |
| WL | Placebo comparator | Device: Dual focus with narrow band imagingConventional white light endoscopy use It is routine practice for the upper gastrointestinal endoscopy. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- consecutive patients who have undergone uper gastrointestinal endoscopy for diagnosis or screening of cancer.
Key exclusion criteria (4 listed)
- Those whose Hp status had already been clarified
- Pregnancy
- History of partial gastrectomy
- Taking proton pump inhibitor, antithrombotics or antibiotics within 4 weeks
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 |
|---|---|---|
| Dual focus with narrow band imagingdual focus mode for imaging magnification + narrow band imaging for the enhancement of mucosal vascularity and irregularity | Device | DF-NBI, WL |
Primary outcome
Accurate prediction of Helicobacter pylori status
Time frame: 1 day
Sensitivity, specificity, PPV, and NPV
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Individual participant dataSharing planned: No. If needed, IPD will be shared.
Related trials for Helicobacter Pylori Infection
RecruitingPhase 3
Keverprazan-Minocycline Dual Therapy of Different Durations Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.
Helicobacter Infection
RecruitingPhase 1
Impact of Eradication Therapy on Helicobacter Pylori Infection With Chronic Obstructive Pulmonary Disease:
Chronic Obstructive Pulmonary Disease (COPD), With Poitive H Pylori
RecruitingObservational study
Feasibility and Performance of FFPE qPCR for Detection of Clarithromycin Resistance in Helicobacter Pylori
HELICOBACTER PYLORI INFECTIONS
RecruitingPhase 4
Efficacy and Safety of Linarazen Gluconate Capsules Combined With Amoxicillin (Dual-Drug Therapy) Versus Bismuth-Containing Quadruple Therapy for First-Line Eradication of Helicobacter Pylori Infection
HELICOBACTER PYLORI INFECTIONS
Not yet recruitingObservational study
European Implementation Study on Simultaneous Screening for Gastric and Colorectal Cancers
Helicobacter Pylori Infection, Colorectal Cancer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual focus with narrow band imaging in people with Helicobacter Pylori Infection, run by Kyunghee University Medical Center 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 4 Jun 2019. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jung-Wook Kim, MD, PhD (82-2-958-8141, iloveact@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accurate prediction of Helicobacter pylori status (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2019.