AutoSTEA for Indigestion

Not currently recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: MetroHealth Medical Center

Must not be taking: Antisecretory, Antidepressants, Prokinetics, NSAIDs

Disqualifiers: Unhealed esophagitis, Ulcer disease, GI cancers, Uncontrolled diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called AutoSTEA to determine its effectiveness for people with functional dyspepsia, which causes upper belly discomfort. Researchers aim to assess whether the device can reduce symptoms and if it is safe and easy to use at home. Participants will wear the device daily for two weeks and report their experiences. Individuals with ongoing upper belly discomfort not fully treated by other medications might be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new device.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if your dyspepsia symptoms are fully resolved by certain medications, you may not be eligible to participate.

What prior data suggests that the AutoSTEA device is safe for treating functional dyspepsia?

Research shows that the AutoSTEA device remains in the early stages of testing. This Phase 1 trial primarily aims to assess the device's safety. In this phase, a small group of people will use the device to observe how their bodies respond and to identify any side effects.

Clear information about side effects is not yet available because AutoSTEA is new and still under evaluation. Phase 1 trials are specifically designed to monitor side effects closely and ensure the treatment's safety.

The device is a band that wraps around the rib cage and uses electrical signals that synchronize with breathing. Participants will complete a safety questionnaire to report any side effects. This process helps researchers understand the device's safety and potential side effects.

As this is the first test of AutoSTEA, participants' experiences are crucial. Their feedback will help determine if the device is safe for future use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for indigestion, which often rely on medications like antacids or proton pump inhibitors to reduce stomach acid, AutoSTEA offers a non-drug approach. This innovative treatment involves a band-like device that wraps around the rib cage, connected to a microstimulator and TENS pads, delivering synchronized electrical impulses with the patient's breathing. Researchers are excited because this method may provide relief without the side effects of medications, offering a new avenue for those with functional dyspepsia.

What evidence suggests that the AutoSTEA device is effective for treating functional dyspepsia?

Research has shown that the AutoSTEA device, provided to participants in this trial, might relieve symptoms of functional dyspepsia, a type of upper abdominal discomfort. The device uses gentle electrical signals to stimulate the body and is designed to synchronize with breathing. This method may manage pain and discomfort by affecting the nerves involved in digestion. Although human data remains limited, early indications suggest the device could benefit those with indigestion. Further research is needed to confirm its effectiveness, but the initial concept appears promising. ^{1 6 7 8 9}

Who Is on the Research Team?

Michael Kurin, MD

Principal Investigator

MetroHealth Medical Center

Are You a Good Fit for This Trial?

This trial is for adults with functional dyspepsia, which means they have ongoing upper abdominal discomfort. They must not have other GI diseases, a history of certain surgeries or cancers in the digestive system, uncontrolled diabetes or severe psychiatric conditions. People who've had their indigestion fully treated by specific medications are also excluded.

Inclusion Criteria

I am 18 years old or older.

I have been diagnosed with functional dyspepsia.

Exclusion Criteria

I have ongoing stomach issues due to NSAIDs, esophagitis, or ulcers.

I have no history of major upper GI surgeries or cancers, uncontrolled diabetes, severe psychiatric conditions, uncontrolled medical disorders, knee replacements, or above-the-knee amputations.

I do not have an active H. pylori infection, or it has been successfully treated.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants use the AutoSTEA device for half an hour every day for two weeks

2 weeks

1 phone check-in

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AutoSTEA

Trial Overview The AutoSTEA device is being tested to see if it can relieve symptoms of indigestion. Participants will use this non-invasive device synchronized with their breathing for 30 minutes daily at home over two weeks and report on its effectiveness and any issues using it.

How Is the Trial Designed?

Group I: Adult patients with functional dyspepsia Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

MetroHealth Medical Center

Lead Sponsor

Trials

125

Recruited

22,600+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07020416

AutoSTEA for Adults With Functional Dyspepsia 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 ...

2. withpower.com withpower.com/trial/phase-1-functional-dyspepsia-1-2025-9f076

AutoSTEA for Indigestion · Info for Participants The goal of this study is to assess how effective the AutoSTEA device is in treating functional dyspepsia (upper abdominal discomfort) in adults.

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/16/NCT07020416/Prot_000.pdf

TEMPLATE PROTOCOL Forty patients with functional dyspepsia (FD) will be enrolled in a two-week, single-arm trial to evaluate the safety and usability of the. AutoSTEA treatment.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8132673/

Functional Dyspepsia: A Review of the Symptoms ... However, studies have shown PPI therapy to be effective in treating functional dyspepsia in only 14% of patients., A meta-analysis of 10 randomized, controlled ...

5. bmcgastroenterol.biomedcentral.com bmcgastroenterol.biomedcentral.com/articles/10.1186/s12876-023-02935-9

Patient-reported outcome measures in functional dyspepsia This systematic review suggests that LPDS is currently the most recommended tool for patient self-assessment of functional dyspepsia symptoms.

6. ctv.veeva.com ctv.veeva.com/study/autostea-for-adults-with-functional-dyspepsia

AutoSTEA for Adults With Functional Dyspepsia The goal of this study is to assess how effective the AutoSTEA device is in treating functional dyspepsia (upper abdominal discomfort) in ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7249902/

A clinical study on safety and efficacy of Naesohwajung- ... Functional dyspepsia (FD) is a chronic gastrointestinal disorder diagnosed with dyspeptic symptoms, such as recurrent or persistent postprandial ...

8. trial.medpath.com trial.medpath.com/clinical-trial/d97714893a853387/nct07020416-electrical-acustimulation-treating-functional-dyspepsia

AutoSTEA for Adults With Functional Dyspepsia | MedPath This will be done using the device safety questionnaire. The safety questionnaire is to filled out weekly, with any adverse event that is ...

9. app.trialscreen.org app.trialscreen.org/trials/phase-1-autostea-adults-functional-dyspepsia-trial-nct07020416

AutoSTEA for Adults With Functional Dyspepsia The goal of this study is to assess how effective the AutoSTEA device is in treating functional dyspepsia (upper abdominal discomfort) in adults ...