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.|
|ClinicalTrials.gov Identifier: NCT01118585|
Recruitment Status : Unknown
Verified February 2017 by EndoGastric Solutions.
Recruitment status was: Active, not recruiting
First Posted : May 6, 2010
Last Update Posted : February 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Gastroesophageal Reflux Disease Hiatal Hernia||Procedure: Transoral Incisionless Fundoplication (TIF)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Completion Date :||December 2017|
Transoral incisionless fundoplication procedure using the EsophyX device.
Procedure: Transoral Incisionless Fundoplication (TIF)
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.
- 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).
- Elimination of Proton Pump Inhibitor (PPI) usage [ Time Frame: at 12-, 24- and 36-month follow-up ]
- 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.
- Healing of reflux esophagitis [ Time Frame: at 12, 24- and 36-month follow-up ]
- Safety outcomes [ Time Frame: first 30 days ]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 ]GERD symptom elimination based on GERD-HRQL, GSRS and RSI scores.
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 ClinicalTrials.gov identifier (NCT number): NCT01118585
|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, Virginia, United States, 20190|
|Principal Investigator:||Reginald CW Bell, MD, FACS||SurgOne P.C.|