Retrospective Transoral Incisionless Fundoplication (TIF) Study for Treatment of Gastroesophageal Reflux Disease (GERD). The RetroTIF Study

This study is enrolling participants by invitation only.

Sponsor:

Information provided by:

EndoGastric Solutions

ClinicalTrials.gov Identifier:

NCT01327963

First received: March 30, 2011

Last updated: March 31, 2011

Last verified: March 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	March 30, 2011
Last Updated Date	March 31, 2011
Start Date ^ICMJE	September 2010
Estimated Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 31, 2011)	Typical and atypical Gastroesophageal Reflux Disease (GERD) symptom elimination [ Time Frame: 12 or 24 months ] [ Designated as safety issue: No ] Typical and atypical GERD symptom elimination (scores ≤ 2 to each question in GERD Health-related Quality of Life (GERD-HRQL), GERD Symptom Score (GERSS) and Reflux Symptom Index (RSI) questionnaires) at the follow-up.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01327963 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 31, 2011)	Serious Adverse Events (SAEs) & Unanticipated Adverse Device Effects (UADEs) [ Time Frame: 12 or 24 months ] [ Designated as safety issue: Yes ] The treatment will be considered safe if the incidence of serious adverse events (SAEs) is below the ranges reported for laparoscopic fundoplication. Elimination of Proton Pump Inhibitors (PPIs) use [ Time Frame: 12 or 24 months ] [ Designated as safety issue: No ] Complete discontinuation will be considered clinically significant. Healing of reflux esophagitis [ Time Frame: 12 or 24 months ] [ Designated as safety issue: No ] One grade reduction will be considered clinically significant. Reduction of hiatal hernia [ Time Frame: 12 or 24 months ] [ Designated as safety issue: No ] Size reduction to < 1 cm will be considered clinically significant. Normalization or clinically significant improvement in esophageal acid exposure and reflux episodes [ Time Frame: 12 or 24 months ] [ Designated as safety issue: No ] Esophageal acid exposure will be measured objectively by 48-hour Bravo pH or 24-hour impedance/pH testing at the follow-up (where pH testing is available). Normalization of esophageal acid exposure will be defined by total time with pH < 4 for ≤ 6% of 24-hour or for ≤ 5.3% of 48-hour monitoring period. The number of reflux episodes of ≤ 44 per each 24-hour period will be considered normal.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Retrospective Transoral Incisionless Fundoplication (TIF) Study for Treatment of Gastroesophageal Reflux Disease (GERD). The RetroTIF Study
Official Title ^ICMJE	Long-term Outcomes After Transoral Incisionless Fundoplication (TIF) Performed in Routine Clinical Practice: The Retro TIF Study
Brief Summary	The purpose of this open-label, postmarket study is to evaluate the safety and efficacy of transoral incisionless fundoplication (TIF) performed with EsophyX in a broad range of gastroesophageal reflux disease (GERD) patients treated at high volume centers across the United States.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Gastroesophageal Reflux Disease
Intervention ^ICMJE	Device: Transoral Incisionless Fundoplication (EsophyX) Transoral incisionless esophago-gastric fundoplication performed using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following the standardized TIF2 protocol. Other Names: Transoral Incisionless Fundoplication TIF
Study Arm (s)	Not Provided
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	Enrolling by invitation
Estimated Enrollment ^ICMJE	180
Estimated Completion Date	September 2012
Estimated Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Age 18-85 years Have undergone the TIF procedure within the past 2 years Availability for a follow-up visit at 12 or 24 months Willingly and cognitively signed informed consent Exclusion Criteria: Procedure not completed or performed following a non-standardized TIF protocol Subjects suffering from other GI conditions such as dyspepsia, celiac disease, IBS or Crohn's disease Pregnancy Enrollment in another device or drug study that may confound the results
Gender	Both
Ages	18 Years to 85 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01327963
Other Study ID Numbers ^ICMJE	D01079
Has Data Monitoring Committee	No
Responsible Party	Emir Deljkich/Medical Affairs Manager & MSL, EndoGastric Solutions
Study Sponsor ^ICMJE	EndoGastric Solutions
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	EndoGastric Solutions
Verification Date	March 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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