Transoral Incisionless Fundoplication (TIF) Registry Study for Treatment of Gastroesophageal Reflux Disease (GERD)
NCT ID: NCT01118585
Last Updated: 2019-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
278 participants
INTERVENTIONAL
2010-05-31
2018-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TIF Procedure
Intervention: 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.. .
TIF Procedure
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.
Interventions
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TIF Procedure
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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EndoGastric Solutions
INDUSTRY
Responsible Party
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Principal Investigators
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Reginald CW Bell, MD, FACS
Role: PRINCIPAL_INVESTIGATOR
SurgOne P.C.
Locations
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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
Countries
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Related Links
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Click here for more information about this study: TIF Registry study
Other Identifiers
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D00960
Identifier Type: -
Identifier Source: org_study_id
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