Gastroesophageal Reflux Disease Clinical Trial
Official title:
Prospective Outcome Evaluation of Transoral Incisionless Fundoplication (TIF) for the Treatment of Gastroesophageal Reflux Disease (GERD): The TIF Registry Study
NCT number | NCT01118585 |
Other study ID # | D00960 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2010 |
Est. completion date | December 2018 |
Verified date | March 2019 |
Source | EndoGastric Solutions |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 278 |
Est. completion date | December 2018 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Allegan Surgical Associates | Allegan | Michigan |
United States | Ihde Surgical Group, PA | Arlington | Texas |
United States | The Surgeons Group of Baton Rouge | Baton Rouge | Louisiana |
United States | Crossville Medical Group | Crossville | Tennessee |
United States | Swedish Medical Center and SurgOne P.C. | Englewood | Colorado |
United States | St Mary's Hospital | Hobart | Indiana |
United States | The University of Texas Health Science Center | Houston | Texas |
United States | Munroe Regional Hospital | Ocala | Florida |
United States | Utah County Surgical Associates | Provo | Utah |
United States | Reston Hospital | Reston | Virginia |
United States | Mt. Graham Regional Medical Center | Safford | Arizona |
United States | Livingston Hospital and Healthcare Services, Inc. CAH | Salem | Kentucky |
United States | Master Center for Minimally Invasive Surgery | Southlake | Texas |
United States | Tempe St. Luke's Hospital | Tempe | Arizona |
Lead Sponsor | Collaborator |
---|---|
EndoGastric Solutions |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Elimination of Proton Pump Inhibitor (PPI) usage | Elimination of Proton Pump Inhibitor (PPI) usage | at 12-, 24- and 36-month follow-up | |
Secondary | Esophageal acid exposure | 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 | |
Secondary | Healing of reflux esophagitis | Healing of reflux esophagitis | at 12, 24- and 36-month follow-up | |
Secondary | Safety outcomes | Incidence of anticipated and unanticipated adverse events | first 30 days | |
Secondary | Long-term Gastroesophageal Reflux Disease (GERD) symptom elimination | GERD symptom elimination based on GERD-HRQL, GSRS and RSI scores. | at 12-, 24- and 36-month follow-up |
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