Retrospective TIF Study for Treatment of Gastroesophageal Reflux Disease (GERD). The RetroTIF Study
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Interventions
- Device: Transoral Incisionless Fundoplication
- Registration Number
- NCT01327963
- Lead Sponsor
- EndoGastric Solutions
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 110
- Age 18-85 years
- Have undergone the TIF procedure within the past 2 years
- History of daily proton pump inhibitor (PPI) use for >6 months
- Proven gastroesophageal reflux by either endoscopy, ambulatory potential of hydrogen (pH) or moderate to severe symptoms on or off PPIs
- Deteriorated gastroesophageal junction (Hill grade II or III)
- Availability for a follow-up visit at 6,12 or 24 months
- Willingly and cognitively signed informed consent
- Procedure not completed or performed following a non-standardized TIF protocol
- Subjects suffering from other gastrointestinal (GI) conditions such as dyspepsia, celiac disease, Irritable bowel syndrome (IBS) or Crohn's disease
- Pregnancy
- Enrollment in another device or drug study that may confound the results
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Transoral Incisionless Fundoplication Transoral Incisionless Fundoplication Intervention: Transoral Incisionless Fundoplication 2.0 technique iteration (TIF 2.0). With patient in general anesthesia. The EsophyX (brand name) 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 GastroEsophageal Junction (GEJ) below the diaphragm, into the abdomen. Multiple prolene fasteners are used to secure and keep in place the plications.
- Primary Outcome Measures
Name Time Method Typical and Atypical Gastroesophageal Reflux Disease (GERD) Symptom Elimination median 7 months (range 5-17 months) 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.
- Secondary Outcome Measures
Name Time Method Number of Participants Reporting Complete Elimination of Proton Pump Inhibitor (PPI) Use median 7 months (range 5-17 months) Patients reporting complete discontinuation of daily PPI use will be considered clinically significant.
Number of Participants With Healing of Reflux Esophagitis median 7 months (range 5-17 months) 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.
Number of Participants Experiencing Serious Adverse Events (SAEs) & Unanticipated Adverse Device Effects (UADEs) median 7 months (range 5-17 months) The treatment will be considered safe if the incidence of serious adverse events (SAEs) is below the ranges reported for laparoscopic fundoplication.
Number of Participants With Normalization or Clinically Significant Improvement in Esophageal Acid Exposure Assessed by Impedance/pH Testing and Reflux Episodes median 7 months (range 5-17 months) 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.
Number of Participants Whose Baseline Hiatal Hernia Has Remained Reduced at Post-TIF Follow-up median 7 months (range 5-17 months) 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.
Trial Locations
- Locations (2)
Livingston Hospital and Healthcare Services, Inc. CAH
🇺🇸Salem, Kentucky, United States
Munroe Regional Medical Center
🇺🇸Ocala, Florida, United States