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

Tracking Information
First Submitted Date ICMJE	April 30, 2010
First Posted Date ICMJE	May 6, 2010
Last Update Posted Date	February 9, 2017
Study Start Date ICMJE	May 2010
Actual Primary Completion Date	June 2015 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 6, 2010)	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).
Original Primary Outcome Measures ICMJE; (submitted: May 5, 2010)	GERD symptoms [ Time Frame: at 6 month follow-up ]; GERD symptom elimination or clinically significant reduction is defined as ≥ 50% improvement in the total QOLRAD, GSRS and RSI scores compared to baseline off PPIs.
Change History	Complete list of historical versions of study NCT01118585 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: April 22, 2013)	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.
Original Secondary Outcome Measures ICMJE; (submitted: May 5, 2010)	Elimination of PPI usage [ Time Frame: at 6 and 12 month follow-up ]; Esophageal acid exposure [ Time Frame: at 6 and 12 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 6 and 12 month follow-up ]; Safety outcomes [ Time Frame: first 30 days ]Incidence of anticipated and unanticipated adverse events; GERD symptoms [ Time Frame: at 12 month follow-up ]GERD symptom elimination or clinically significant reduction is defined as ≥ 50% improvement in the total QOLRAD, GSRS and RSI scores compared to baseline off PPIs.
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Transoral Incisionless Fundoplication (TIF) Registry Study for Treatment of Gastroesophageal Reflux Disease (GERD)
Official Title ICMJE	Prospective Outcome Evaluation of Transoral Incisionless Fundoplication (TIF) for the Treatment of Gastroesophageal Reflux Disease (GERD): The TIF Registry Study
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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Gastroesophageal Reflux Disease; Hiatal Hernia
Intervention ICMJE	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.
Study Arms	TIF Procedure; Transoral incisionless fundoplication procedure using the EsophyX device.; Intervention: Procedure: Transoral Incisionless Fundoplication (TIF)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Active, not recruiting
Estimated Enrollment ICMJE; (submitted: May 5, 2010)	500
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	December 2017
Actual Primary Completion Date	June 2015 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 75 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01118585
Other Study ID Numbers ICMJE	D00960
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Plan to Share IPD: Undecided
Responsible Party	EndoGastric Solutions
Study Sponsor ICMJE	EndoGastric Solutions
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Reginald CW Bell, MD, FACS SurgOne P.C.
PRS Account	EndoGastric Solutions
Verification Date	February 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP