AutoSTEA for Adults With Functional Dyspepsia

NCT07020416 | Active Not Recruiting Phase 1

• 1 other identifier: STUDY00000169
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (3)

• Determine the device safety when self-administered at home by patients

  Assess any adverse effects the device may have when used by patients in their home. This will be done using the device safety questionnaire. The safety questionnaire is to filled out weekly, with any adverse event that is experienced being reported. These adverse events (if applicable) will be rated in severity on a 0-5 scale, with 0 being the least severe and 5 being the most severe.

  From enrollment to the end of treatment in two weeks

• Evaluate device usability

  Assess how easy the device is for patients to use in their home. This will be done using the usability questionnaire. This questionnaire will be filled out daily and the user will rate on a 0-5 scale (with 0 being the worst and 5 being the best) how easy and comfortable the device was for them.

  From enrollment to the end of treatment in two weeks

• Assess symptom responses to treatment

  Assess how well a patient's dyspepsia symptoms respond to the treatment. This will be done via two questionnaires. One will be filled out weekly, where patients describe how much their dyspepsia symptoms have affected their daily lives. The scale for this will be 0-4, with 0 being no effect on their daily life and 5 being extreme effect on their daily lives. The second questionnaire will be filled out daily, and it describes the physical dyspepsia symptoms experienced by the patient in the last 24 hours. It is done on a scale from 0-10, with 0 meaning they have not experienced a symptom at all, and 10 being they have severely experienced a symptom.

  From enrollment to the end of treatment in two weeks

Secondary Outcomes (2)

• Assess a diverse participant pool, especially overweight/obese female patients

  From enrollment to the end of treatment in two weeks

• Assess patient's compliance to AutoSTEA treatment

  From enrollment to the end of treatment in two weeks

Study Arms (1)

Adult patients with functional dyspepsia

EXPERIMENTAL

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.

Device: Transcutaneous electrical acustimulation in automatic synchronization with breathing

Interventions

Transcutaneous electrical acustimulation in automatic synchronization with breathing DEVICE

This intervention will be carried out via the AutoSTEA device.

Adult patients with functional dyspepsia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• MetroHealth Medical Center: lead

Study Sites (2)

MetroHealth Medical Center - Main Campus

Cleveland, Ohio, 44109, United States

Location

MetroHealth Parma Medical Center

Parma, Ohio, 44130, United States

Location

Study Officials

• Michael Kurin, MD

  MetroHealth Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: June 13, 2025
• Study Start: February 26, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)