This is a prospective, multi-center, double-blind, crossover, randomized controlled trial designed to demonstrate the safety and efficacy of Aluvra for the treatment of GERD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Keck School of Medicine of USC
Los Angeles, California, United States
Digestive Health Center
Palo Alto, California, United States
SOFI - Center for Esophageal Wellness
Englewood, Colorado, United States
Efficacy of Aluvra- GERD HRQL
Efficacy will be established through two co-primary objectives. The first co-primary endpoint will be to compare response rates between treatment group and control group at 12 months based on the GERD-Health Related Quality of Life questionnaire.
Time frame: 12 months
Efficacy of Aluvra- Esophageal PH
Efficacy will be established through two co-primary objectives. The second co-primary endpoint will be to compare change from baseline in total percent time esophageal pH \<4 between the treatment group vs. the sham control group at 12 months.
Time frame: 12 months
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Mayo Clinic Florida
Jacksonville, Florida, United States
Esophageal Institute of Atlanta
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Washington University in Saint Louis
St Louis, Missouri, United States
The Oregon Clinic, Gastrointestinal and Minimally Invasive Surgery Division
Portland, Oregon, United States
Aurora Medical Center Summit
Milwaukee, Wisconsin, United States