MetroHealth Medical Center
The goal of this study is to assess the acceptance and usability as well as safety of the AutoSTEA device is in treating epigastric pain syndrome in adults. It will also explore preliminary clinical and mechanistic signals. The main questions it aims to answer are: * Does the AutoSTEA device ease epigastric pain symptoms? * Is the AutoSTEA device safe and feasible for patients to use at their home? Participants will: * Use the device for 30-60 minutes at home each day for 4 weeks * Have a phone check-in four times through the trial (once a week). * Answer the daily and weekly questionnaires which consist of questions regarding symptoms, device usability, and adverse events experienced.
Inclusion Criteria: * At least 18 years of age * Diagnosed with epigastric pain syndrome according to Rome V Criteria * Experienced epigastric pain at least 3 days a week for at least 3 months * Must have normal esophagogastroduodenoscopy performed in last 2 years Exclusion Criteria: * Any history of gastritis, gastric/duodenal ulcers, or other organic upper GI diseases * Current drug or alcohol abuse * Currently pregnant or planning to become pregnant * History of major abdominal surgery * History of severe mental illness * Total knee-replacement surgery or above-the-knee amputation * Any…
The AutoSTEA device is a device that detects the user's respiration wave and synchronizes each breath to deliver electrical stimulation at acupuncture points via skin surface electrodes. With this automated synchronization device, patients can inhale and exhale with an uninterrupted and normal respiration pace while receiving the TEA treatment, largely simplifying the treatment procedures, improving patients' compliance, and enhancing the effectiveness of the method.
The sham treatment is the same as the AutoSTEA device except that it doesn't synchronize with users breathing. It still does deliver the same electric shocks.
Arctuva estimate
Actual pay is set by the research site.
Verify or correct the compensation shown for this listing.