The purpose of this retrospective, open-label, post-market study is to evaluate the safety and efficacy of Transoral Incisionless Fundoplication (TIF) performed with EsophyX (brand name) in a broad range of GastroEsophageal Reflux Disease (GERD) patients treated at high volume centers across the United States.
This retrospective, open-label, post-market study evaluates the safety and efficacy of Transoral Incisionless Fundoplication (TIF) performed with EsophyX (brand name) in a broad range of GastroEsophageal Reflux Disease (GERD) patients treated at high volume centers across the United States, in clinical routine practice, as standard of care.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
110
Transoral incisionless esophago-gastric fundoplication performed using the EsophyX (brand name) system with SerosaFuse (brand name) fasteners (EndoGastric Solutions, Inc., Redmond, Washington, USA) and following the standardized Transoral Incisionless Fundoplication 2.0 technique iteration (TIF2.0) protocol.
Munroe Regional Medical Center
Ocala, Florida, United States
Livingston Hospital and Healthcare Services, Inc. CAH
Salem, Kentucky, United States
Typical and Atypical Gastroesophageal Reflux Disease (GERD) Symptom Elimination
Typical and atypical GERD symptom elimination in GERD Health-Related Quality of Life (GERD-HRQL). HRQL questionnaire measures typical GERD symptoms, scale 0-5 for each of 9 questions; scores considered normalized if every score is 0), GERD Symptom Score (GERSS measures atypical GERD symptoms, scale 0-3 for severity and 0-4 for frequency, with total scale 0-60; patients with controlled reflux symptoms are expected to have a score of \<18) and Reflux Symptom Index (RSI measures atypical laryngopharyngeal (LPR) symptoms, scale 0-5 for each of 9 questions with maximum of 45 with a normality threshold of \< or = 13) questionnaires) at the follow-up.
Time frame: median 7 months (range 5-17 months)
Number of Participants Experiencing Serious Adverse Events (SAEs) & Unanticipated Adverse Device Effects (UADEs)
The treatment will be considered safe if the incidence of serious adverse events (SAEs) is below the ranges reported for laparoscopic fundoplication.
Time frame: median 7 months (range 5-17 months)
Number of Participants Reporting Complete Elimination of Proton Pump Inhibitor (PPI) Use
Patients reporting complete discontinuation of daily PPI use will be considered clinically significant.
Time frame: median 7 months (range 5-17 months)
Number of Participants With Healing of Reflux Esophagitis
One LA grade reduction will be considered clinically significant. LA grades are A, B, C, D, with A being the least severe esophagitis. No grade assigned is considered "normal", i.e. no esophagitis reported.
Time frame: median 7 months (range 5-17 months)
Number of Participants Whose Baseline Hiatal Hernia Has Remained Reduced at Post-TIF Follow-up
Measurement obtained by study investigator, under endoscopic visualization using cm markings on the endoscope. Outcome measure assesses if hiatal hernia that was present at baseline and reduced (size reduction to \< 1 cm is considered clinically significant) during TIF procedure, has remained reduced at the post-TIF follow up exam.
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Time frame: median 7 months (range 5-17 months)
Number of Participants With Normalization or Clinically Significant Improvement in Esophageal Acid Exposure Assessed by Impedance/pH Testing and Reflux Episodes
Esophageal acid exposure will be measured objectively by 48-hour Bravo Potential of Hydrogen (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 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.
Time frame: median 7 months (range 5-17 months)