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ACTIVE NOT RECRUITING
NCT07020416
PHASE1

AutoSTEA for Adults With Functional Dyspepsia

Sponsor: MetroHealth Medical Center

View on ClinicalTrials.gov

Summary

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.

Official title: Transcutaneous Electrical Acustimulation in Automatic Synchronization With Breathing for Treating Functional Dyspepsia: A Phase I Feasibility Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-02-26

Completion Date

2027-02

Last Updated

2025-06-13

Healthy Volunteers

No

Interventions

DEVICE

Transcutaneous electrical acustimulation in automatic synchronization with breathing

This intervention will be carried out via the AutoSTEA device.

Locations (2)

MetroHealth Medical Center - Main Campus

Cleveland, Ohio, United States

MetroHealth Parma Medical Center

Parma, Ohio, United States