A Phase 2 interventional study of Transoral incisional fundoplication in Fundoplication and GERD, sponsored by Chinese University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by Chinese University of Hong Kong · Phase 2, Interventional, and Treatment
Transoral incisionless fundoplication (TIF) has become a widely used intervention to restore the valve at the gastroesophageal junction in selected patients suffering from gastroesophageal reflux disease (GERD). More than 20,000 procedures have been performed worldwide. TIF with EsophyX device reconfigures the tissue to establish an omega-shaped full-thickness gastroesophageal valve from inside the stomach. The procedure creates serosa to serosa plications which include the muscle layers and constructs valves 3-5cm long, taking in 200-270 degrees of the circumference, and deploying multiple non-absorbable polypropylene fasteners through the two layers in a circumferential patten around the gastroesophageal junction. Data so far indicate that, in the majority of patients, the procedure achieves lasting improvement in GERD symptoms measured by either pH or impedance monitoring. The technique offers an acceptable alternative to surgery, mimicking partial fundoplication, but less invasive and with no persistent side effects, in patients with proven pathological GERD with either a competent gastroesophageal valve or hiatal hernia, not longer than 3cm, who refuse, are intolerance, or are unresponsive to PPI maintenance therapy. Laparoscopic fundoplication, although still considered to be the gold-standard approach for GERD refractory to medical treatment, does involve some risk of long-term adverse events such as dysphagia (5-12%), inability to vomit or belch, gas/bloat syndrome (19%) and excessive flatulence.
Several prospective observational studies and some comparative trials have proved efficacy of TIF with EsophyX in obtaining a significant reduction in the acid exposure time (AET) assessed by esophageal 24-hour pH-impedance monitoring versus sham, and in controlling both typical and atypical GERD symptoms for up to 1 to 2 years, as reported in a meta-analysis7. Outcomes at 3, 5, and 10 years have been reported in different studies and showed to be favourable. In an Italian study reporting the 10 year follow-up, the GERD-HRQL score, heartburn and regurgitation score were significantly lower than pre-procedure and did not change significantly during the follow-up. The rates of patients who had stopped or halved anti-secretive therapy 2, 3, 5, 7 and 10 years after the procedure were 86.7%, 84.4%, 73.5%, 83.3% and 91.7% respectively.
This procedure, however, has not been performed in Asia patients. Asians have smaller body build and is known to have less GERD when compared to the Caucasian population. This study, therefore, is a feasibility study to perform TIF in an Asian population.
In patients who fulfil the inclusion criteria, TIF will be performe under general anaesthesia. They will then be followed-up at 4 weeks, 3 months, then yearly for up to 5 years after the procedure. The anti-reflux control and adverse events will be recorded.
Transoral incisionless fundoplication (TIF) has become a widely used intervention to restore the valve at the gastroesophageal junction in selected patients suffering from gastroesophageal reflux disease (GERD). More than 20,000 procedures have been performed worldwide. TIF with EsophyX device reconfigures the tissue to establish an omega-shaped full-thickness gastroesophageal valve from inside the stomach. The procedure creates serosa to serosa plications which include the muscle layers and constructs valves 3-5cm long, taking in 200-270 degrees of the circumference, and deploying multiple non-absorbable polypropylene fasteners through the two layers in a circumferential patten around the gastroesophageal junction. Data so far indicate that, in the majority of patients, the procedure achieves lasting improvement in GERD symptoms measured by either pH or impedance monitoring. The technique offers an acceptable alternative to surgery, mimicking partial fundoplication, but less invasive and with no persistent side effects, in patients with proven pathological GERD with either a competent gastroesophageal valve or hiatal hernia, not longer than 3cm, who refuse, are intolerance, or are unresponsive to PPI maintenance therapy. Laparoscopic fundoplication, although still considered to be the gold-standard approach for GERD refractory to medical treatment, does involve some risk of long-term adverse events such as dysphagia (5-12%), inability to vomit or belch, gas/bloat syndrome (19%) and excessive flatulence. Several prospective observational studies and some comparative trials have proved efficacy of TIF with EsophyX in obtaining a significant reduction in the acid exposure time (AET) assessed by esophageal 24-hour pH-impedance monitoring versus sham, and in controlling both typical and atypical GERD symptoms for up to 1 to 2 years, as reported in a meta-analysis7. Outcomes at 3, 5, 6 and 10 years have been reported in different studies and showed to be favourable. In an Italian study reporting the 10-year follow-up, the GERD-HRQL score, heartburn and regurgitation score were significantly lower than pre-procedure and did not change significantly during the follow-up. The rates of patients who had stopped or halved anti-secretive therapy 2, 3, 5, 7 and 10 years after the procedure were 86.7%, 84.4%, 73.5%, 83.3% and 91.7% respectively.
This procedure, however, has not been performed in Asia patients. Asians have smaller body build and is known to have less GERD when compared to the Caucasian population. This study, therefore, is a feasibility study to perform TIF in an Asian population.
This study will show that TIF, apart being effective in western population, is also feasible and effective in Asian patients.
1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.
This study's planned enrollment of 20 is below the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Transoral incisional fundoplication for GERD patients
Procedure: Transoral incisional fundoplication
Transoral incisional fundoplication offered for GERD patients. This procedure, however, has not been performed in Asia patients, even with previous success with other studies. Asians have smaller body build and is known to have less GERD when compared to the Caucasian population. This study, therefore, is a feasibility study to perform TIF in an Asian population
Also known as: GERD
Elimination of Regurgitation and Troublesome Atypical Symptoms - RDQ
Elimination of troublesome regurgitation and elimination of all troublesome atypical symptoms at the 1-year follow-up as evaluated by the Reflux Disease Questionnaire (RDQ). RDQ with total score ranging from 0 to 18 based on symptom frequency over the past week. Higher score indicates a higher likelihood of GERD, and it is also used to measure treatment response.
Time frame: 1 year
Elimination of Regurgitation and Troublesome Atypical Symptoms - GERD-QOL
Elimination of troublesome regurgitation and elimination of all troublesome atypical symptoms at the 1-year follow-up as evaluated by the GERD-QOL score.
Time frame: 1 year
Improvement of Symptom Scores - RDQ
Measuring the improvement in symptom scores using the (RDQ) at 4 Weeks, 3, 12, 24, 36, 48, 60 months post-TIF. RDQ with total score ranging from 0 to 18 based on symptom frequency over the past week. Higher score indicates a higher likelihood of GERD, and it is also used to measure treatment response.
Time frame: at 4 Weeks, 3, 12, 24, 36, 48, 60 months post-TIF
Improvement of Symptom Scores - GERD-QOL on PPI
Measuring the improvement in symptom scores using the GERD-QOL score on PPI at 4 Weeks, 3, 12, 24, 36, 48, 60 months post-TIF. The GERD-QOL questionnaire is an 18-item instrument assessing the impact of gastroesophageal reflux disease on daily life, including sleep, diet, work, and social activity over the past 7 days. It uses a 5-point scale per item (0=Strongly agree to 4=Strongly disagree), where a higher score indicates a better quality of life.
Time frame: at 4 Weeks, 3, 12, 24, 36, 48, 60 months post-TIF
Improvement of Symptom Scores - GERD-QOL off PPI
Measuring the improvement in symptom scores using the GERD-QOL score off PP at 4 Weeks, 3, 12, 24, 36, 48, 60 months post-TIF
Time frame: at 4 Weeks, 3, 12, 24, 36, 48, 60 months post-TIF
Dosage and Frequency of Proton Pump Inhibitors Usage
The usage of proton pump inhibitor, that is dosage of frequency of its use for the patients will be recorded
Time frame: 5 years from recruitment
Measurement for Reflux
24hr pH study will be used for determining the reflux situation for patients, post-surgery.
Time frame: At recruitment, 12 months Post-TIF, 24 months post-TIF, 36 months post-TIF, 48 months post-TIF and 60 months post-TIF
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Chinese University of Hong Kong