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

NCT ID: NCT02935881

Last Updated: 2016-10-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RFA (Stretta Procedure)

Radio Frequency Ablation (RFA) using a Stretta device.

Group Type: ACTIVE_COMPARATOR

Radio Frequency Ablation (RFA) (Stretta Procedure)

Intervention Type: DEVICE

Radio Frequency Ablation (RFA) for the treatment of refractory gastroesophageal reflux disease.

Placebo Arm

Stretta device used but RFA will not be generated.

Group Type: SHAM_COMPARATOR

Sham Procedure

Intervention Type: PROCEDURE

Stretta device will be used but Radio Frequency Ablation (RFA) will not be generated.

Interventions

Radio Frequency Ablation (RFA) (Stretta Procedure)

Radio Frequency Ablation (RFA) for the treatment of refractory gastroesophageal reflux disease.

Intervention Type: DEVICE

Sham Procedure

Stretta device will be used but Radio Frequency Ablation (RFA) will not be generated.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age > 18years
• Small hiatus hernia (< 2-3 cm)
• Los Angeles Grade 'A' or 'B' Reflux Esophagitis
• LES pressure : 5 - 15 mm Hg
• PPI dependent / refractory GERD
• 24 hr acid exposure study showing abnormal esophageal acid exposure > 4%
• DeMeester Score >14.7
• Esophageal manometry showing normal peristalsis

Exclusion Criteria

• Age < 18 years
• Large hiatus hernia (> 3 cm)
• Los Angeles Grade 'C' or 'D' Reflux Esophagitis
• LES pressure : < 5 or > 15 mm Hg
• Underlying coagulation disorder
• Previous Esophageal or Gastric surgery
• H/o coronary artery disease (CAD)
• Esophageal manometry showing ineffective peristalsis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asian Institute of Gastroenterology, India

OTHER

Sponsor Role: lead

Responsible Party

Rakesh K

consultant gastroenterologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kalapala Rakesh, MD,DM

Role: PRINCIPAL_INVESTIGATOR

Asian Institute of Gastroenterology

Locations

Asian insititute of gastroenterology somajiguda, hyderabad india

Hyderabad, Telangana, India

Site Status: RECRUITING

Countries

India

Facility Contacts

Kalapala Dr Rakesh, consultant

Role: primary

drkalapala@gmail.com

9989211034 ext. 040-23378482

Other Identifiers

aigstretta 001

Identifier Type: -

Identifier Source: org_study_id