Retrospective TIF Study for Treatment of Gastroesophageal Reflux Disease (GERD). The RetroTIF Study (RetroTIF)
|ClinicalTrials.gov Identifier: NCT01327963|
Recruitment Status : Terminated (The sponsor is focusing on prospective randomized studies)
First Posted : April 4, 2011
Last Update Posted : February 9, 2017
|Condition or disease||Intervention/treatment|
|Gastroesophageal Reflux Disease (GERD)||Device: Transoral Incisionless Fundoplication (EsophyX)|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Long-term Outcomes After Transoral Incisionless Fundoplication (TIF) Performed in Routine Clinical Practice: The Retro TIF Study|
|Study Start Date :||September 2010|
|Primary Completion Date :||February 2014|
|Study Completion Date :||February 2014|
Experimental: Transoral Incisionless Fundoplication
Transoral Incisionless Fundoplication:
With patient in general anesthesia. The EsophyX device is introduced through the mouth, over a standard endoscope, into the stomach. Multiple gastro -esophageal plications are performed, apposing the fundus to the distal part of the esophagus and repositioning the GEJ below the diaphragm, into the abdomen. multiple prolene fasteners are used to sescure and keep in place the plications.
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.
- Typical and atypical Gastroesophageal Reflux Disease (GERD) symptom elimination [ Time Frame: 12 or 24 months ]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.
- Serious Adverse Events (SAEs) & Unanticipated Adverse Device Effects (UADEs) [ Time Frame: 12 or 24 months ]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 ]Complete discontinuation will be considered clinically significant.
- Healing of reflux esophagitis [ Time Frame: 12 or 24 months ]One grade reduction will be considered clinically significant.
- Reduction of hiatal hernia [ Time Frame: 12 or 24 months ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01327963
|United States, Indiana|
|Saint Mary Medical Center|
|Hobart, Indiana, United States, 46342|
|United States, Kentucky|
|Livingston Hospital and Healthcare Services, Inc. CAH|
|Salem, Kentucky, United States, 42078|
|United States, Michigan|
|Allegan Surgical Associates, P.C.|
|Allegan, Michigan, United States, 49010|
|United States, Texas|
|Ihde Surgical Group, PA|
|Arlington, Texas, United States, 76014|
|United States, Virginia|
|Reston Surgical Associates|
|Reston, Virginia, United States, 20190|
|Principal Investigator:||Erik Wilson, MD FACS||The University of Texas Health Science Center, Houston|