Retrospective TIF Study for Treatment of Gastroesophageal Reflux Disease (GERD). The RetroTIF Study (RetroTIF)
Gastroesophageal Reflux Disease (GERD)
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux Disease (GERD) focused on measuring Gastroesophageal reflux disease, GERD, Heartburn, Reflux, Regurgitation, Hoarseness, Cough
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Munroe Regional Medical Center
- Livingston Hospital and Healthcare Services, Inc. CAH
Arms of the Study
Arm 1
Experimental
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.