AutoSTEA for Adults With Functional Dyspepsia

MetroHealth Medical Center

Status and phase: Active, not recruiting; Phase 1

Conditions: Functional Dyspepsia

Treatments: Device: Transcutaneous electrical acustimulation in automatic synchronization with breathing

Study type: Interventional

Funder types: Other

Identifiers

NCT07020416

STUDY00000169

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 and older
• Must meet Rome IV criteria for functional dyspepsia

Exclusion criteria

• 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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Adult patients with functional dyspepsia

Experimental group

Description:

The treatment this arm will be administered is the AutoSTEA treatment, which consists of a band-like device that wraps around the rib cage. This device is connected to a microstimulator which is then connected to TENS pads. The band allows for the electrical impulses given to be synchronized with one's breathing.

Treatment:

Device: Transcutaneous electrical acustimulation in automatic synchronization with breathing