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

Completed · Not applicable

Conditions studied: Gastroesophageal Reflux Disease, Hiatal Hernia

In brief

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.

Key facts

Study ID

NCT01118585

Run by

EndoGastric Solutions

People needed

278

Starts

2010-05-01

Expected to finish

2018-12-01

Last updated by the study team

2019-03-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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