Hernia Reduction Prior to Scheduled TIF Completion using EsophyX ZR transoral device
Evaluation of the relative merits, safety and effectiveness of the EsophyX ZR transoral device in performing the standardized TIF 2.0 procedure preceded by laparoscopic Hiatal Hernia repair in PPI-prescribed patients with persistent "troublesome symptoms" per the Montreal consensus definition
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
TIF
Elkhart General Hospital
Elkhart, Indiana, United States
Aspirus Iron River Hospital
Iron River, Michigan, United States
Northern Nevada Medical Center
Sparks, Nevada, United States
pH Study
Number of Participants with Normalization of Esophageal Acid Exposure. Normalization in esophageal acid exposure is defined by ≤ 5.3% of total time pH \< 4 in
Time frame: 48 hour monitoring period
Number of Participants With a Change in Troublesome Symptoms From Baseline
Per Montreal Consensus definition, troublesome symptoms are mild symptoms occurring two (2) or more days per week, or moderate/severe symptoms occurring more than 1 day per week
Time frame: 6 months
Number of Participants With a Change in PPI Consumption From Baseline to 6 Months
from daily use to occasional use or none at all.
Time frame: 6 months
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