New hope for heartburn: keyhole-free fix tested in asians for first time
NCT ID NCT07556289
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a procedure called TIF (transoral incisionless fundoplication) for people with chronic acid reflux (GERD) who don't get relief from medication. It is done through the mouth, no cuts, and aims to rebuild the valve between the stomach and esophagus. The study will enroll 20 Asian adults and follow them for up to 5 years to see if symptoms improve and if they can reduce or stop acid-reducing drugs.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2021
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 18 years - 80 years of age * More than 6 months of GERD symptoms and troublesome regurgitation, despite a minimum PPI dose of 40 mg daily. Troublesome regurgitation was defined as mild symptoms for 2 or more days per week or moderate to severe symptoms more than 1 day per week, per Montreal consensus criteria. Patients will be followed-up for 5 years. * Symptom assessment used the following 3 validated tools: the Reflux Disease Questionnaire (RDQ), and the GERD-QOL score on PPI and off PPI for at least 7 days. * Abnormal amounts of gastroesophageal reflux off PPI for 7 days was confirmed by distal esophageal pH \<4 for \>5.3% of at least 1 of the 2 days that pH was measured with a Bravo (radiotelemetry) probe (Given Imaging, Yoqneam, Israel). Exclusion Criteria: * Systemic disease not well controlled * Obesity determined by body mass index \>35 * Esophageal ulcer, stricture * Barrett's esophagus \>2 cm in length * Hiatal hernia \>2 cm in length * Los Angeles grade C or D esophagitis * Peptic ulcer disease * Gastroparesis * Pregnancy or plans for pregnancy in the next 12 months * Immunosuppression * Portal hypertension * Coagulopathy
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Chinese University of Hong Kong, Shatin, HK
RECRUITINGHong Kong, Hong Kong
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can banding the esophagus stop reflux? a small trial tests the idea
- Can a less invasive reflux surgery match the standard one?
- Can thread acupuncture boost GERD relief beyond standard pills?
- Could a simple probe placement change improve GERD diagnosis for millions?
- Could a simple neck band protect transplanted lungs from stomach acid?
- Unnecessary test? study questions routine throat tube before reflux surgery