Transoral Incisionless Fundoplication (TIF) Registry Study for Treatment of Gastroesophageal Reflux Disease (GERD)

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01118585
• Other study ID #: D00960
• Status: Completed
• Phase: N/A
• Start date: May 2010
• Est. completion date: December 2018

Study information

• Verified date: March 2019
• Source: EndoGastric Solutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Esophagitis, Peptic
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease
• Hernia, Hiatal
• Hiatal Hernia

Intervention

Procedure:
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
EndoGastric Solutions

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Click here for more information about this study: TIF Registry study