AutoSTEA for Adults With Functional Dyspepsia
Running, not enrolling · Phase 1
Conditions studied: Functional Dyspepsia
In brief
The goal of this study is to assess how effective the AutoSTEA device is in treating functional dyspepsia (upper abdominal discomfort) in adults. It will also assess the safety and usability of the device. The main questions it aims to answer are: * Does the AutoSTEA device ease dyspepsia symptoms? * Is the AutoSTEA device safe and feasible for patients to use at their home? Participants will: * Use the device for half an hour every day for two weeks * Have a phone check-in halfway through the trial * Answer the daily and weekly questionnaires which consist of questions regarding symptoms, device usability, and adverse events experienced.
Key facts
- Study ID
- NCT07020416
- Run by
- MetroHealth Medical Center
- People needed
- 20
- Starts
- 2025-02-26
- Expected to finish
- 2027-02-01
- Last updated by the study team
- 2025-06-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18 and older
- Must meet Rome IV criteria for functional dyspepsia
You may not qualify if…
- Patients with dyspepsia symptoms that have been fully resolved by antisecretory, antidepressant, or prokinetic therapy
- History of active NSAID use, unhealed esophagitis, unhealed ulcer disease, or other GI diseases that can explain their dyspepsia symptoms.
- History of upper GI surgeries and upper GI cancers, uncontrolled diabetes (type 1 and 2), severe psychiatric conditions, uncontrolled medical disorders, total knee replacement surgery, or above-the-knee amputation.
- Patients with H. pylori infection without confirmed eradication will also be excluded.
Where it is running
- MetroHealth Medical Center - Main Campus — Cleveland, Ohio, United States
- MetroHealth Parma Medical Center — Parma, Ohio, United States
Full record on ClinicalTrials.gov
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