NCT02935881

STRETTA ,Radio Frequency Ablation (RFA) v/s Sham Therapy for the Treatment of Refractory GERD

A Prospective Randomized Trial Comparing Endoscopic Radio Frequency Ablation (RFA) - STRETTA vs Sham Therapy for the Treatment of Refractory Gastroesophageal Reflux Disease

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Asian Institute of Gastroenterology, India · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Gastro-esophageal reflux disease (GERD) is a chronic disorder with significant impact on the quality of life of patients. It may also lead to several complications like peptic strictures, ulcerations, Barrett 's disease and subsequently adenocarcinoma of the esophagus. Proton pump inhibitors (PPIs) are the mainstay of GERD treatment, with up to 90 % of patients with reflux disease becoming asymptomatic while taking PPIs. Several studies have demonstrated that RF delivery at the gastro-esophageal junction(GEJ), also called the Stretta procedure, induces symptom relief and decreases need of PPI intake in GERD. The investigators propose to perform a sham-controlled randomized study to evaluate the influence of the Stretta procedure on symptoms and esophageal acid exposure in patients of refractory GERD.

Detailed description

Gastro-esophageal reflux disease (GERD) is a chronic disorder with significant impact on the quality of life of patients. It may also lead to several complications like peptic strictures, ulcerations, Barrett 's disease and subsequently adenocarcinoma of the esophagus. Proton pump inhibitors (PPIs) are the mainstay of GERD treatment, with up to 90 % of patients with reflux disease becoming asymptomatic while taking PPIs. However, the treatment of patients with proven GERD, who have an unsatisfactory response to high doses of PPIs remains a challenge. A number of endoscopic procedures, aimed at improvement of the barrier function of the lower esophageal sphincter (LES), have emerged over the last decade. Several studies have demonstrated that RF delivery at the gastro-esophageal junction(GEJ), also called the Stretta procedure, induces symptom relief and decreases need of PPI intake in GERD. The investigators propose to perform a sham-controlled randomized study to evaluate the influence of the Stretta procedure on symptoms and esophageal acid exposure in patients of refractory GERD.

Conditions

• GERD

Interventions

Type	Name	Description
DEVICE	Radio Frequency Ablation (RFA) (Stretta Procedure)	Radio Frequency Ablation (RFA) for the treatment of refractory gastroesophageal reflux disease.
PROCEDURE	Sham Procedure	Stretta device will be used but Radio Frequency Ablation (RFA) will not be generated.

Timeline

• Start date: 2015-01-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2016-10-18
• Last updated: 2016-10-18

Locations

1 site across 1 country: India