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The EndoGastric Solutions TEMPO Trial

NCT01647958 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2020-11-23

Study results available
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Summary

The purpose of this study is to assess the efficacy and safety of Transoral Incisionless Fundoplication (TIF) performed with EsophyX as compared to proton pump inhibitor (PPI) therapy for the treatment of chronic Gastroesophageal Reflux Disease (GERD) patients with refractory symptoms on Proton Pump Inhibitors (PPIs).

Conditions

  • Gastroesophageal Reflux Disease (GERD)

Interventions

DEVICE

EsophyX System with SerosaFuse fasteners

Transoral Incisionless Fundoplication (TIF)/Transoral incisionless esophago-gastric fundoplication using the EsophyX System with SerosaFuse fasteners

DRUG

PPI

Control Arm participants will take maximum standard dose of PPI during Initial Study period

Sponsors & Collaborators

  • EndoGastric Solutions

    lead INDUSTRY

Principal Investigators

  • Karim Trad, MD, FACS · Reston Surgical Associates

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-06-01
Primary Completion
2015-10-01
Completion
2017-12-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01647958 on ClinicalTrials.gov