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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
EndoGastric Solutions
ClinicalTrials.gov Identifier:
NCT01118585
First received: April 30, 2010
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Gastroesophageal Reflux Disease
Hiatal Hernia
Procedure: Transoral Incisionless Fundoplication (TIF) using EsophyX
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by EndoGastric Solutions:

Primary Outcome Measures:
  • Gastroesophageal Reflux Disease (GERD) symptom elimination [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
    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:
  • Elimination of Proton Pump Inhibitor (PPI) usage [ Time Frame: at 12-, 24- and 36-month follow-up ] [ Designated as safety issue: No ]
  • Esophageal acid exposure [ Time Frame: at 6-, 12-, 24- and 36-month follow-up ] [ Designated as safety issue: No ]
    Normalization of esophageal acid exposure is defined as ≤ 4.3% of 24-hour period or ≤ 5.3% of 48-hour period at pH < 4.

  • Healing of reflux esophagitis [ Time Frame: at 12, 24- and 36-month follow-up ] [ Designated as safety issue: No ]
  • Safety outcomes [ Time Frame: first 30 days ] [ Designated as safety issue: Yes ]
    Incidence of anticipated and unanticipated adverse events

  • Long-term Gastroesophageal Reflux Disease (GERD) symptom elimination [ Time Frame: at 12-, 24- and 36-month follow-up ] [ Designated as safety issue: No ]
    GERD symptom elimination based on GERD-HRQL, GSRS and RSI scores.


Estimated Enrollment: 500
Study Start Date: May 2010
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
TIF Procedure
TIF procedure using EsophyX
Procedure: Transoral Incisionless Fundoplication (TIF) using EsophyX
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01118585

Locations
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
Investigators
Principal Investigator: Reginald CW Bell, MD, FACS SurgOne P.C.
  More Information

No publications provided

Responsible Party: EndoGastric Solutions
ClinicalTrials.gov Identifier: NCT01118585     History of Changes
Other Study ID Numbers: D00960
Study First Received: April 30, 2010
Last Updated: April 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by EndoGastric Solutions:
GERD
Esophagitis
Fundoplication
Anti-reflux surgery
PPI dependent

Additional relevant MeSH terms:
Gastroesophageal Reflux
Hernia, Hiatal
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases
Hernia
Hernia, Diaphragmatic
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on November 27, 2014