Clinical trial NCT01118585: Transoral Incisionless Fundoplication (TIF) Registry Study for Treatment of Gastroesophageal Reflux Disease (GERD)
Official title: Prospective Outcome Evaluation of Transoral Incisionless Fundoplication (TIF) for the Treatment of Gastroesophageal Reflux Disease (GERD): The TIF Registry Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux Disease
Hiatal Hernia
Keywords: GERD
Esophagitis
Fundoplication
Anti-reflux surgery
PPI dependent
Lead sponsor: EndoGastric Solutions
Sponsor class: INDUSTRY
First posted: 2010-05-06
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Gastroesophageal Reflux Disease (GERD) symptom elimination
timeFrame: 6-month follow-up
Secondary outcomes:
measure: Elimination of Proton Pump Inhibitor (PPI) usage
timeFrame: at 12-, 24- and 36-month follow-up
measure: Esophageal acid exposure
timeFrame: at 6-, 12-, 24- and 36-month follow-up
measure: Healing of reflux esophagitis
timeFrame: at 12, 24- and 36-month follow-up
measure: Safety outcomes
timeFrame: first 30 days
measure: Long-term Gastroesophageal Reflux Disease (GERD) symptom elimination
timeFrame: at 12-, 24- and 36-month follow-up
Other outcomes:
Locations:
city: Safford
country: United States
facility: Mt. Graham Regional Medical Center
state: Arizona
city: Tempe
country: United States
facility: Tempe St. Luke's Hospital
state: Arizona
city: Englewood
country: United States
facility: Swedish Medical Center and SurgOne P.C.
state: Colorado
city: Ocala
country: United States
facility: Munroe Regional Hospital
state: Florida
city: Hobart
country: United States
facility: St Mary's Hospital
state: Indiana
city: Salem
country: United States
facility: Livingston Hospital and Healthcare Services, Inc. CAH
state: Kentucky
city: Baton Rouge
country: United States
facility: The Surgeons Group of Baton Rouge
state: Louisiana
city: Allegan
country: United States
facility: Allegan Surgical Associates
state: Michigan
city: Crossville
country: United States
facility: Crossville Medical Group
state: Tennessee
city: Arlington
country: United States
facility: Ihde Surgical Group, PA
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center
state: Texas
city: Southlake
country: United States
facility: Master Center for Minimally Invasive Surgery
state: Texas
city: Provo
country: United States
facility: Utah County Surgical Associates
state: Utah
city: Reston
country: United States
facility: Reston Hospital
state: Virginia
Study officials:
affiliation: SurgOne P.C.
name: Reginald CW Bell, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: