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New treatment option for Fundoplication
Official title Transoral Incisional Fundoplication (TIF) for Patients Suffering From Gastroesophageal Reflux Disease in an Asian Population
ClinicalTrials.gov ID: NCT07556289
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- 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...
- Abnormal amounts of gastroesophageal reflux off PPI for 7 days was confirmed by distal esophageal pH \ 5.3% of at least 1 of the 2 days that pH was...
You likely can't join if
- 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
See the full eligibility 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...
- 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 \ 5.3% of at least 1 of the 2 days that pH was measured with a Bravo (radiotelemetry) probe (Given Imaging, Yoqneam...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong, Hong Kong
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hong Kong, Hong Kong. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.