Transoral incisionless fundoplication (TIF) for GERD in Asian adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional protocol uses the EsophyX device to perform transoral incisionless fundoplication (TIF), creating an omega-shaped full-thickness gastroesophageal valve from inside the stomach. Eligible adults (18–80) must have pathological reflux confirmed off PPI by Bravo pH monitoring and at least six months of troublesome regurgitation despite ≥40 mg daily PPI. The procedure creates serosa-to-serosa plications with polypropylene fasteners to form a 3–5 cm valve spanning about 200–270 degrees of the circumference. Patients are followed for up to five years with symptom questionnaires and pH/impedance monitoring to evaluate durability and safety.

Why it matters

Who can join: the full rules

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

Where it's running

• The Chinese University of Hong Kong, Shatin, HK
  Hong Kong, Hong Kong Recruiting

Study contacts

• Study coordinator: Shannon Melissa CHAN, MBChB, FRCSEd, FHKAM (Surgery)
• Email: shannonchan@surgery.cuhk.edu.hk
• Phone: +852 3505 2956

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.