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

GERD Clinical Trial

— STRETTAGERD  

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 Details — Status: Recruiting

Administrative data

• NCT number: NCT02935881
• Other study ID #: aigstretta 001
• Status: Recruiting
• Phase: Phase 3
• First received: October 11, 2016
• Last updated: October 14, 2016
• Start date: January 2015
• Est. completion date: January 2017

Study information

• Verified date: October 2016
• Source: Asian Institute of Gastroenterology, India
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• GERD

Intervention

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.

Locations

Country	Name	City	State
India	Asian insititute of gastroenterology somajiguda, hyderabad india	Hyderabad	Telangana

Sponsors (1)

Lead Sponsor	Collaborator
Asian Institute of Gastroenterology, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who report improvement in Quality of Life (QOL) post Stretta procedure as compared to Sham therapy.	6 point GERD Likert Scale will be used to assess the improvement in frequency and severity of GERD symptoms post Stretta procedure & Sham therapy amongst patients.	1 year	No
Secondary	Number of patients who report independence from Proton Pump Inhibitor (PPI) drug post Stretta procedure as compared to Sham therapy.	Questionnaire will be provided to each participant to report no further requirement of PPI drug post procedure.	1 year	No
Secondary	Comparison of Increased Lower Esophageal Sphincter pressure among patients post Stretta procedure & Sham Therapy.	High Resolution Esophageal Manometry will be performed after the procedure in each patient to compare the LES pressure between the two groups.	1 year	No