Clinical Trials Logo
  1. Home
  2. GERD
  3. NCT02935881

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

GERD Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02935881
Study type Interventional
Source Asian Institute of Gastroenterology, India
Contact
Status Recruiting
Phase Phase 3
Start date January 2015
Completion date January 2017
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT06084572 - Prospective Evaluation of pH-impedance Tracings According to the Wingate Consensus, and Influence on GERD Classification According to the Lyon Consensus
Completed NCT03568825 - Response Surface Pathway Design With Two Interventional- and One Response Variable in Estimating Minimum Efficacy Dose N/A
Recruiting NCT04703374 - A Study to Compare PK, PD and Safety of CKD-382 in Healthy Subjects Phase 1
Completed NCT04120025 - Effectiveness of Diaphragmatic Breathing on Reflux Symptoms in Outpatients N/A
Withdrawn NCT04771247 - Endoscopic Cardiac Band Ligation for the Management of Refractory GERD After Laparoscopic Sleeve Gastrectomy N/A
Completed NCT02575287 - Minimal Injuries From Esophagus Detected by Optical Enhancement System™ Associated to Optical Magnification HD Scopes N/A
Completed NCT01710800 - Twenty-Four Hour Combined Multi-Channel Impedance and pH Ambulatory Monitoring: Impedance Reflux Episodes of Patients On and Off Proton Pump Inhibitor Therapy N/A
Completed NCT00287339 - The Utility of Nexium in Chronic Cough and Reflux Disease Phase 4
Completed NCT00287391 - Sleep Disorders and Gastroesophageal Reflux Disease (GERD) Phase 4
Completed NCT00629564 - An Open, Randomized, Two Way Crossover Study Comparing the Effect of 20mg Esomeprazole Administered Orally and Intravenously as a 15 Minute Infusion on Basal and Pentagastrin-Stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD) Phase 4
Completed NCT04243668 - ANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA) N/A
Completed NCT03558477 - PK/PD Clinical Trial of YYD601 in Healthy Adult Male Phase 1
Recruiting NCT05042063 - Acoustic Cough Monitoring for the Management of Patients With Known Respiratory Disease
Completed NCT05069493 - Long-term Follow-up After Hiatal Hernia Repair by Tension-free Mesh Closure or Simple Suturing
Terminated NCT04626232 - Comparison of the Sleeve Gastrectomy Technique With a Nissen Fundoplication Added to the Conventional Sleeve Gastrectomy Technique in Morbidly Obese Patients N/A
Completed NCT03238534 - Efficacy and Safety Evaluation of Neobianacid® in GERD and EPS Phase 4
Recruiting NCT05974722 - Mesh Vs Pledgets for Repair of Paraesophageal Hernia N/A
Recruiting NCT05781347 - Stretta Versus Conservative Treatment in Obese and Non-obese N/A
Completed NCT06141577 - A Study to Compare Pharmacokinetics, Pharmacodynamics and Safety of UI059 and UIC202201 in Healthy Subjects Phase 1
Recruiting NCT05108038 - A Study to Evaluate the PK, PD and Safety of CKD-382 in Healthy Subjects Phase 1