Gastroesophageal Reflux Disease, Hiatal Hernia
Conditions
Keywords
GERD, Esophagitis, Fundoplication, Anti-reflux surgery, PPI dependent
Brief summary
The study objective is to evaluate the safety and efficacy of TIF among a broad range of GERD patients treated in routine clinical practice at multiple centers across the United States.
Detailed description
Primary Effectiveness Endpoint: Typical and atypical GERD symptom elimination (scores ≤ 2 to each question) or clinically significant improvement (≥ 50% reduction in total scores) at 6-month follow-up compared to baseline. Secondary Effectiveness Endpoints: GERD symptom elimination or clinically significant improvement at 12-month follow-up, 24-month follow-up and 36-month follow-up; complete discontinuation of PPIs; normalization of esophageal acid exposure; significant reduction in reflux episodes; healing of reflux esophagitis; reduction of hiatal hernia; safety supported by low incidence of serious adverse events.
Interventions
PROCEDURETIF Procedure
The TIF procedure results in the creation of an esophago-gastric fundoplication extending up to 4 cm above the Z-line and 270 degrees around the esophagus.
Sponsors
EndoGastric Solutions
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-75 years * GERD for \> 1 year * History of daily PPIs use for \> 6 months * Moderate to severe typical or atypical GERD symptoms off PPIs * Complete (responders) or partial (nonresponders) symptom control on PPIs * Deteriorated gastroesophageal junction (Hill grade II or III) * Proven gastroesophageal reflux by either endoscopy, ambulatory pH or barium swallow testing * Willingness to undergo pH/impedance testing, if required * Willingness to cooperate with the postoperative diet for 6 weeks * Availability for follow up visits at 6 months and 12 months * Willingly and cognitively signed informed consent
Exclusion criteria
* BMI \> 35 * Incompletely reducible hiatal hernia with residual of \> 5 mm * Esophagitis grade D * Barrett's Esophagus \> 2 cm * Esophageal ulcer * Fixed esophageal stricture or narrowing * Portal hypertension and/or varices * Active gastro-duodenal ulcer disease * Gastric outlet obstruction or stenosis * Gastroparesis or delayed gastric emptying confirmed by solid-phase gastric emptying study, if patient complains of postprandial satiety during assessment * Coagulation disorder * History of any of the following: resective gastric or esophageal surgery, antireflux surgery with anatomy unsuitable for TIF procedure per physician judgment, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis * Pregnancy or plans of pregnancy in the next 12 months * Enrollment in another device or drug study that may confound the results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastroesophageal Reflux Disease (GERD) symptom elimination | 6-month follow-up | GERD symptoms (typical and atypical) will be evaluated using three disease-specific standardized questionnaires: GERD-HRQL (Health-related Quality of Life), GSRS (GERD Symptom Rating Score), and RSI (Reflux Symptom Index). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Elimination of Proton Pump Inhibitor (PPI) usage | at 12-, 24- and 36-month follow-up | Elimination of Proton Pump Inhibitor (PPI) usage |
| Esophageal acid exposure | at 6-, 12-, 24- and 36-month follow-up | Normalization of esophageal acid exposure is defined as ≤ 4.3% of 24-hour period or ≤ 5.3% of 48-hour period at pH \< 4. |
| Healing of reflux esophagitis | at 12, 24- and 36-month follow-up | Healing of reflux esophagitis |
| Safety outcomes | first 30 days | Incidence of anticipated and unanticipated adverse events |
| Long-term Gastroesophageal Reflux Disease (GERD) symptom elimination | at 12-, 24- and 36-month follow-up | GERD symptom elimination based on GERD-HRQL, GSRS and RSI scores. |
Countries
United States
Outcome results
None listed