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AutoSTEA for Adults With Functional Dyspepsia

NCT07020416 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-06-13

No results posted yet for this study

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.

Conditions

  • Functional Dyspepsia

Interventions

DEVICE

Transcutaneous electrical acustimulation in automatic synchronization with breathing

This intervention will be carried out via the AutoSTEA device.

Sponsors & Collaborators

  • MetroHealth Medical Center

    lead OTHER

Principal Investigators

  • Michael Kurin, MD · MetroHealth Medical Center

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-26
Primary Completion
2026-04-30
Completion
2027-02-28

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07020416 on ClinicalTrials.gov