Transoral incisionless fundoplication (TIF) for GERD in Asian adults

Transoral Incisional Fundoplication (TIF) for Patients Suffering From Gastroesophageal Reflux Disease in an Asian Population

This tests whether a less-invasive transoral incisionless fundoplication (TIF) procedure can reduce reflux symptoms in Asian adults who continue to have GERD despite daily PPI treatment.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Chinese University of Hong Kong (other)
• Locations: 1 site (Hong Kong)
• Trial ID: NCT07556289 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–80 with documented pathological GERD off PPI, at least six months of troublesome regurgitation despite ≥40 mg daily PPI, hiatal hernia ≤2 cm, BMI ≤35, and ability to attend follow-up visits are ideal candidates.

Not a fit: Patients with Barrett's esophagus >2 cm, hiatal hernia >2 cm, esophageal ulcer or stricture, uncontrolled systemic disease, BMI >35, or severe esophageal motility disorders are unlikely to benefit.

Why it matters

Potential benefit: If successful, TIF could lessen reflux symptoms and reduce long-term reliance on PPIs while avoiding some risks associated with laparoscopic fundoplication.

How similar studies have performed: Similar EsophyX TIF procedures have been performed in over 20,000 patients worldwide and prior studies report durable symptom and acid-exposure improvements for many patients.

Eligibility criteria

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 this trial is running

Hong Kong

• The Chinese University of Hong Kong, Shatin, HK — Hong Kong, Hong Kong (RECRUITING)

Study contacts

• Study coordinator: Shannon Melissa CHAN, MBChB, FRCSEd, FHKAM (Surgery)

Conditions: Fundoplication, GERD