Search > Indigestion
My employer runs this trial

AutoSTEA Device for Indigestion

Not yet recruiting at 1 trial location
DV
Overseen ByDonovan Veccia
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: MetroHealth Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this study is to assess the acceptance and usability as well as safety of the AutoSTEA device is in treating epigastric pain syndrome in adults. It will also explore preliminary clinical and mechanistic signals. The main questions it aims to answer are:

* Does the AutoSTEA device ease epigastric pain symptoms?

* Is the AutoSTEA device safe and feasible for patients to use at their home?

Participants will:

* Use the device for 30-60 minutes at home each day for 4 weeks

* Have a phone check-in four times through the trial (once a week).

* Answer the daily and weekly questionnaires which consist of questions regarding symptoms, device usability, and adverse events experienced.

Are You a Good Fit for This Trial?

This trial is for adults who have indigestion with upper stomach pain (epigastric pain syndrome). Participants must be able to use a device at home daily and answer questionnaires. Specific inclusion or exclusion details are not provided.

Inclusion Criteria

I have been diagnosed with epigastric pain syndrome.
Must have normal esophagogastroduodenoscopy performed in last 2 years
I am 18 years old or older.
See 1 more

Exclusion Criteria

Currently pregnant or planning to become pregnant
I have had major abdominal surgery in the past.
Current drug or alcohol abuse
See 9 more

What Are the Treatments Tested in This Trial?

Interventions

  • AutoSTEA device

Trial Overview

The study tests the AutoSTEA device, which is used at home for 30-60 minutes daily over 4 weeks, compared to a sham (inactive) treatment. The main focus is on safety, ease of use, and whether it helps relieve symptoms.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Treatment First ArmExperimental Treatment1 Intervention
Group II: Sham first armExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

MetroHealth Medical Center

Lead Sponsor

Trials
125
Recruited
22,600+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

Unbiased Results

We believe in providing patients with all the options.

Your Data Stays Your Data

We only share your information with the clinical trials you're trying to access.

Verified Trials Only

All of our trials are run by licensed doctors, researchers, and healthcare companies.