Transoral Incisionless Fundoplication (TIF) Registry Study for Treatment of Gastroesophageal Reflux Disease (GERD)
Prospective Outcome Evaluation of Transoral Incisionless Fundoplication (TIF) for the Treatment of Gastroesophageal Reflux Disease (GERD): The TIF Registry Study
1 other identifier
interventional
278
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2010
Longer than P75 for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2010
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedFirst Posted
Study publicly available on registry
May 6, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedMarch 6, 2019
March 1, 2019
5.1 years
April 30, 2010
March 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gastroesophageal Reflux Disease (GERD) symptom elimination
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 Outcomes (5)
Elimination of Proton Pump Inhibitor (PPI) usage
at 12-, 24- and 36-month follow-up
Esophageal acid exposure
at 6-, 12-, 24- and 36-month follow-up
Healing of reflux esophagitis
at 12, 24- and 36-month follow-up
Safety outcomes
first 30 days
Long-term Gastroesophageal Reflux Disease (GERD) symptom elimination
at 12-, 24- and 36-month follow-up
Study Arms (1)
TIF Procedure
OTHERIntervention: 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.. .
Interventions
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 Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Mt. Graham Regional Medical Center
Safford, Arizona, 85546, United States
Tempe St. Luke's Hospital
Tempe, Arizona, 85281, United States
Swedish Medical Center and SurgOne P.C.
Englewood, Colorado, 80110, United States
Munroe Regional Hospital
Ocala, Florida, 34471, United States
St Mary's Hospital
Hobart, Indiana, 46342, United States
Livingston Hospital and Healthcare Services, Inc. CAH
Salem, Kentucky, 42078, United States
The Surgeons Group of Baton Rouge
Baton Rouge, Louisiana, 70808, United States
Allegan Surgical Associates
Allegan, Michigan, 49010, United States
Crossville Medical Group
Crossville, Tennessee, 38555, United States
Ihde Surgical Group, PA
Arlington, Texas, 76014, United States
The University of Texas Health Science Center
Houston, Texas, 77030, United States
Master Center for Minimally Invasive Surgery
Southlake, Texas, 76092, United States
Utah County Surgical Associates
Provo, Utah, 84604, United States
Reston Hospital
Reston, Virginia, 20190, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Reginald CW Bell, MD, FACS
SurgOne P.C.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2010
First Posted
May 6, 2010
Study Start
May 1, 2010
Primary Completion
June 1, 2015
Study Completion
December 1, 2018
Last Updated
March 6, 2019
Record last verified: 2019-03