NCT02935881

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 11, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

2 years

First QC Date

October 11, 2016

Last Update Submit

October 14, 2016

Conditions

GERD

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Number of patients who report independence from Proton Pump Inhibitor (PPI) drug post Stretta procedure as compared to Sham therapy.

    1 year

  • Comparison of Increased Lower Esophageal Sphincter pressure among patients post Stretta procedure & Sham Therapy.

    1 year

Study Arms (2)

RFA (Stretta Procedure)

ACTIVE COMPARATOR

Radio Frequency Ablation (RFA) using a Stretta device.

Device: Radio Frequency Ablation (RFA) (Stretta Procedure)

Placebo Arm

SHAM COMPARATOR

Stretta device used but RFA will not be generated.

Procedure: Sham Procedure

Interventions

Radio Frequency Ablation (RFA) (Stretta Procedure)DEVICE

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

RFA (Stretta Procedure)
Sham ProcedurePROCEDURE

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

Placebo Arm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • hr acid exposure study showing abnormal esophageal acid exposure \> 4%
  • DeMeester Score \>14.7
  • Esophageal manometry showing normal peristalsis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asian insititute of gastroenterology somajiguda, hyderabad india

Hyderabad, Telangana, 500082, India

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Kalapala Rakesh, MD,DM

    Asian Institute of Gastroenterology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
consultant gastroenterologist

Study Record Dates

First Submitted

October 11, 2016

First Posted

October 18, 2016

Study Start

January 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

October 18, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)