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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01118585
Recruitment Status : Completed
First Posted : May 6, 2010
Last Update Posted : March 6, 2019
Information provided by (Responsible Party):
EndoGastric Solutions

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Hiatal Hernia Procedure: TIF Procedure Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 278 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Outcome Evaluation of Transoral Incisionless Fundoplication (TIF) for the Treatment of Gastroesophageal Reflux Disease (GERD): The TIF Registry Study
Study Start Date : May 2010
Actual Primary Completion Date : June 2015
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
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 Name: TIF - Transoral Incisionless fundoplication

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. Elimination of Proton Pump Inhibitor (PPI) usage [ Time Frame: at 12-, 24- and 36-month follow-up ]
    Elimination of Proton Pump Inhibitor (PPI) usage

  2. 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.

  3. Healing of reflux esophagitis [ Time Frame: at 12, 24- and 36-month follow-up ]
    Healing of reflux esophagitis

  4. Safety outcomes [ Time Frame: first 30 days ]
    Incidence of anticipated and unanticipated adverse events

  5. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01118585

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United States, Arizona
Mt. Graham Regional Medical Center
Safford, Arizona, United States, 85546
Tempe St. Luke's Hospital
Tempe, Arizona, United States, 85281
United States, Colorado
Swedish Medical Center and SurgOne P.C.
Englewood, Colorado, United States, 80110
United States, Florida
Munroe Regional Hospital
Ocala, Florida, United States, 34471
United States, Indiana
St Mary's Hospital
Hobart, Indiana, United States, 46342
United States, Kentucky
Livingston Hospital and Healthcare Services, Inc. CAH
Salem, Kentucky, United States, 42078
United States, Louisiana
The Surgeons Group of Baton Rouge
Baton Rouge, Louisiana, United States, 70808
United States, Michigan
Allegan Surgical Associates
Allegan, Michigan, United States, 49010
United States, Tennessee
Crossville Medical Group
Crossville, Tennessee, United States, 38555
United States, Texas
Ihde Surgical Group, PA
Arlington, Texas, United States, 76014
The University of Texas Health Science Center
Houston, Texas, United States, 77030
Master Center for Minimally Invasive Surgery
Southlake, Texas, United States, 76092
United States, Utah
Utah County Surgical Associates
Provo, Utah, United States, 84604
United States, Virginia
Reston Hospital
Reston, Virginia, United States, 20190
Sponsors and Collaborators
EndoGastric Solutions
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Principal Investigator: Reginald CW Bell, MD, FACS SurgOne P.C.
Additional Information:
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Responsible Party: EndoGastric Solutions Identifier: NCT01118585    
Other Study ID Numbers: D00960
First Posted: May 6, 2010    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by EndoGastric Solutions:
Anti-reflux surgery
PPI dependent
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Hernia, Hiatal
Pathological Conditions, Anatomical
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Hernia, Diaphragmatic