NCT03223116

Radiofrequency Energy Delivery for Gastroesophageal Reflux Disease

Radiofrequency Energy Delivery for Gastroesophageal Reflux Disease: A Prospective, Multicenter Clinical Trial From China

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the safety and efficacy of radiofrequency energy procedure for Gastro-esophageal reflux disease (GERD) based on changes of symptoms, medication esophagitis grade, esophageal acid exposure and lower esophageal sphincter pressure. Symptom assessment was performed at baseline and 3, 6, 12 months after treatment.

Detailed description

Gastroesophageal reflux disease (GERD) is a chronic disease characterized by symptoms of heartburn and acid regurgitation. Uncontrolled GERD can significantly impact quality of life. The use of proton pump inhibitors (PPI) remains the mainstay therapy. However, the efficacy of this intervention is often hampered by adherence, costs, and the risks of long-term PPI use. Anti-reflux surgery is an option for patients with refractory symptoms or in those in whom medical therapy is contraindicated or not desirable, but the incidence of dysphagia, abdominal distension associated wth the surgery is high. Radiofrequency ablation, minimally invasive, less complications, has become alternative treatments options. But the current research on radiofrequency treatment of the data is limited in China. Therefore, the investigators conduct this multi-center clinical trial.

Conditions

• Gastroesophageal Reflux Disease

Interventions

Type	Name	Description
PROCEDURE	Radiofrequency delivery	Radiofrequency to the gastroesophageal junction

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-09-01
• Completion: 2018-07-01
• First posted: 2017-07-19
• Last updated: 2017-07-19

Locations

1 site across 1 country: China