Transoral Incisionless Fundoplication (TIF) Registry Study for Treatment of Gastroesophageal Reflux Disease (GERD)

March 4, 2019 updated by: EndoGastric Solutions

Prospective Outcome Evaluation of Transoral Incisionless Fundoplication (TIF) for the Treatment of Gastroesophageal Reflux Disease (GERD): The TIF Registry Study

The study objective is to evaluate the safety and efficacy of TIF among a broad range of GERD patients treated in routine clinical practice at multiple centers across the United States.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary Effectiveness Endpoint: Typical and atypical GERD symptom elimination (scores ≤ 2 to each question) or clinically significant improvement (≥ 50% reduction in total scores) at 6-month follow-up compared to baseline.

Secondary Effectiveness Endpoints: GERD symptom elimination or clinically significant improvement at 12-month follow-up, 24-month follow-up and 36-month follow-up; complete discontinuation of PPIs; normalization of esophageal acid exposure; significant reduction in reflux episodes; healing of reflux esophagitis; reduction of hiatal hernia; safety supported by low incidence of serious adverse events.

Study Type

Interventional

Enrollment (Actual)

278

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Safford, Arizona, United States, 85546
        • Mt. Graham Regional Medical Center
      • Tempe, Arizona, United States, 85281
        • Tempe St. Luke's Hospital
    • Colorado
      • Englewood, Colorado, United States, 80110
        • Swedish Medical Center and SurgOne P.C.
    • Florida
      • Ocala, Florida, United States, 34471
        • Munroe Regional Hospital
    • Indiana
      • Hobart, Indiana, United States, 46342
        • St Mary's Hospital
    • Kentucky
      • Salem, Kentucky, United States, 42078
        • Livingston Hospital and Healthcare Services, Inc. CAH
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • The Surgeons Group of Baton Rouge
    • Michigan
      • Allegan, Michigan, United States, 49010
        • Allegan Surgical Associates
    • Tennessee
      • Crossville, Tennessee, United States, 38555
        • Crossville Medical Group
    • Texas
      • Arlington, Texas, United States, 76014
        • Ihde Surgical Group, PA
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center
      • Southlake, Texas, United States, 76092
        • Master Center for Minimally Invasive Surgery
    • Utah
      • Provo, Utah, United States, 84604
        • Utah County Surgical Associates
    • Virginia
      • Reston, Virginia, United States, 20190
        • Reston Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-75 years
  • GERD for > 1 year
  • History of daily PPIs use for > 6 months
  • Moderate to severe typical or atypical GERD symptoms off PPIs
  • Complete (responders) or partial (nonresponders) symptom control on PPIs
  • Deteriorated gastroesophageal junction (Hill grade II or III)
  • Proven gastroesophageal reflux by either endoscopy, ambulatory pH or barium swallow testing
  • Willingness to undergo pH/impedance testing, if required
  • Willingness to cooperate with the postoperative diet for 6 weeks
  • Availability for follow up visits at 6 months and 12 months
  • Willingly and cognitively signed informed consent

Exclusion Criteria:

  • BMI > 35
  • Incompletely reducible hiatal hernia with residual of > 5 mm
  • Esophagitis grade D
  • Barrett's Esophagus > 2 cm
  • Esophageal ulcer
  • Fixed esophageal stricture or narrowing
  • Portal hypertension and/or varices
  • Active gastro-duodenal ulcer disease
  • Gastric outlet obstruction or stenosis
  • Gastroparesis or delayed gastric emptying confirmed by solid-phase gastric emptying study, if patient complains of postprandial satiety during assessment
  • Coagulation disorder
  • History of any of the following: resective gastric or esophageal surgery, antireflux surgery with anatomy unsuitable for TIF procedure per physician judgment, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis
  • Pregnancy or plans of pregnancy in the next 12 months
  • Enrollment in another device or drug study that may confound the results

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: TIF Procedure
Intervention: Transoral incisionless fundoplication procedure using the EsophyX device. During general anesthesia the EsophyX device is introduced trans orally into the stomach and used to created a 270 degree, 3cm in length, wrap at the distal end of the esophagus to treat GERD.. .
Procedure: TIF Procedure
The TIF procedure results in the creation of an esophago-gastric fundoplication extending up to 4 cm above the Z-line and 270 degrees around the esophagus.
Other Names:
  • TIF - Transoral Incisionless fundoplication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastroesophageal Reflux Disease (GERD) symptom elimination
Time Frame: 6-month follow-up
GERD symptoms (typical and atypical) will be evaluated using three disease-specific standardized questionnaires: GERD-HRQL (Health-related Quality of Life), GSRS (GERD Symptom Rating Score), and RSI (Reflux Symptom Index).
6-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Elimination of Proton Pump Inhibitor (PPI) usage
Time Frame: at 12-, 24- and 36-month follow-up
Elimination of Proton Pump Inhibitor (PPI) usage
at 12-, 24- and 36-month follow-up
Esophageal acid exposure
Time Frame: at 6-, 12-, 24- and 36-month follow-up
Normalization of esophageal acid exposure is defined as ≤ 4.3% of 24-hour period or ≤ 5.3% of 48-hour period at pH < 4.
at 6-, 12-, 24- and 36-month follow-up
Healing of reflux esophagitis
Time Frame: at 12, 24- and 36-month follow-up
Healing of reflux esophagitis
at 12, 24- and 36-month follow-up
Safety outcomes
Time Frame: first 30 days
Incidence of anticipated and unanticipated adverse events
first 30 days
Long-term Gastroesophageal Reflux Disease (GERD) symptom elimination
Time Frame: at 12-, 24- and 36-month follow-up
GERD symptom elimination based on GERD-HRQL, GSRS and RSI scores.
at 12-, 24- and 36-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EndoGastric Solutions

Investigators

  • Principal Investigator: Reginald CW Bell, MD, FACS, SurgOne P.C.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

April 30, 2010

First Submitted That Met QC Criteria

May 5, 2010

First Posted (Estimate)

May 6, 2010

Study Record Updates

Last Update Posted (Actual)

March 6, 2019

Last Update Submitted That Met QC Criteria

March 4, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D00960

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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