Functional DyspepsiaPhase 1NCT07020416
AutoSTEA for Adults With Functional Dyspepsia
A Phase 1 study testing Transcutaneous electrical acustimulation in automatic synchronization with breathing in people with Functional Dyspepsia, run by MetroHealth Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- Transcutaneous electrical acustimulation in automatic synchronization with breathing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Feb 2025to Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 and older
- Must meet Rome IV criteria for functional dyspepsia
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
MetroHealth Medical Center - Main Campus
Cleveland, Ohio, 44109
MetroHealth Parma Medical Center
Parma, Ohio, 44130
About this study
Official title: Transcutaneous Electrical Acustimulation in Automatic Synchronization With Breathing for Treating Functional Dyspepsia: A Phase I Feasibility Trial
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
- Being tested
- Transcutaneous electrical acustimulation in automatic synchronization with breathing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical acustimulation in automatic synchronization with breathingDevice
This intervention will be carried out via the AutoSTEA device.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Transcutaneous electrical acustimulation in automatic synchronization with breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment in two weeks
Secondary outcomes (2)
Assess a diverse participant pool, especially overweight/obese female patients
Assess the response that patients have with a focus on those who are overweight/obese and female. This will be analyzed via the two dyspepsia symptom questionnaires that are mentioned in outcome 3.
Measured: From enrollment to the end of treatment in two weeks
Assess patient's compliance to AutoSTEA treatment
Assess if patients followed through with the required usage of the device and treatment. This will be done via their own self-reporting to study staff of if they missed any treatment days.
Measured: From enrollment to the end of treatment in two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start26 Feb 2025
- Primary completionApr 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Kurin, MD, Principal investigator, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020416
- Sponsor's protocol ID
- STUDY00000169
- Status last verified
- Jun 2025
- First submitted
- 30 Apr 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This data is preliminary data which we will use for IP protection and pattern application. We will keep the data confidential prior to future publication.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Acustimulation in Automatic Synchronization With Breathing for Treating Functional Dyspepsia: A Phase I Feasibility Trial
- ClinicalTrials.gov ID
- NCT07020416
- Acronym / sponsor ID
- STUDY00000169
- Conditions
- Functional Dyspepsia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with functional dyspepsia | Experimental | Device: Transcutaneous electrical acustimulation in automatic synchronization with breathingThe 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 and older
- Must meet Rome IV criteria for functional dyspepsia
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous electrical acustimulation in automatic synchronization with breathingThis intervention will be carried out via the AutoSTEA device. | Device | Adult patients with functional dyspepsia |
Primary outcome
Determine the device safety when self-administered at home by patients
Time frame: From enrollment to the end of treatment in two weeks
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.
Evaluate device usability
Time frame: From enrollment to the end of treatment in two weeks
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.
Assess symptom responses to treatment
Time frame: From enrollment to the end of treatment in two weeks
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.
2 secondary outcomes
Assess a diverse participant pool, especially overweight/obese female patients
Time frame: From enrollment to the end of treatment in two weeks
Assess patient's compliance to AutoSTEA treatment
Time frame: From enrollment to the end of treatment in two weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: No. This data is preliminary data which we will use for IP protection and pattern application. We will keep the data confidential prior to future publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Kurin, MD principal investigator
MetroHealth Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Transcutaneous electrical acustimulation in automatic synchronization with breathing in people with Functional Dyspepsia, run by MetroHealth Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the device safety when self-administered at home by patients (time frame: From enrollment to the end of treatment in two weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.