Clinical Research Directory

Potassium Competitive Acid Blocker (PCAB) Test-Guided vs Physiologic Test-Guided Treatment in Patients With Typical Reflux Symptoms

The goal of this clinical trial is to learn if a short course of a potassium-competitive acid blocker (PCAB) test can guide treatment of adults with typical reflux symptoms as effectively as standard physiologic testing with endoscopy and 24-hour pH-impedance monitoring. It will also learn about the safety of PCAB-guided management. The main questions it aims to answer are: * Is PCAB test-guided treatment as effective as physiologic test-guided treatment in improving reflux symptoms after 4 weeks? * How accurate is the PCAB test at detecting pathologic acid reflux compared with 24-hour pH-impedance monitoring? * What medical problems do participants have when receiving PCAB-, proton-pump inhibitor-, or neuromodulator-based treatment? * In this study, researchers will compare two strategies: one group will receive a 7-day course of vonoprazan (PCAB) as a diagnostic test and then treatment guided by the PCAB response, while the other group will undergo endoscopy and 24-hour pH-impedance monitoring with treatment guided by those results. Participants will: * Be randomly assigned to either the PCAB test-guided group or the physiologic test-guided group * Take study medicines by mouth (such as vonoprazan, omeprazole, and/or nortriptyline or matching placebos) for about 4 weeks, depending on their test results and symptom type * Attend scheduled clinic visits for checkups, questionnaires, and safety monitoring * Keep a diary of their reflux symptoms, quality of life, and any use of rescue antacid medicine

Omega Cuff for GERD Feasibility Study

This clinical feasibility study is to evaluate the performance of the Omega-Cuff in the treatment of acid reflux for up to 15 patients with a 1-year follow-up period. The Omega-shaped nitinol device is placed on top of the esophageal sphincter muscle just above the stomach in a laparoscopic surgical procedure without altering anatomy. In animal studies, the device safely increased the pressure on the sphincter, meaning it increased resistance to acid reflux, but did not interfere with normal food swallowing, meaning food went down to the stomach normally and smoothly. The device is intended to augment the function of the weak sphincter in minimizing acid reflux but allows easy swallowing of food in GERD patients. The clinical feasibility study is to see how well this device functions in patients and to assess its safety profile. This is a permanent implant that will last the lifetime of the patient. The device will not interfere with patients who may need diagnostic MRI scans. The device can be safely removed if needed.