Epigastric Pain SyndromePhase 1NCT07917598
TEA Synchronized With Natural Breathing for EPS
A Phase 1 study testing AutoSTEA device in people with Epigastric Pain Syndrome, run by MetroHealth Medical Center at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epigastric Pain Syndrome
- What is being tested?
- AutoSTEA device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2027to 1 Jul 2030
- 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
- At least 18 years of age
- Diagnosed with epigastric pain syndrome according to Rome V Criteria
- Experienced epigastric pain at least 3 days a week for at least 3 months
- Must have normal esophagogastroduodenoscopy performed in last 2 years
Who cannot join
- Any history of gastritis, gastric/duodenal ulcers, or other organic upper GI diseases
- Current drug or alcohol abuse
- Currently pregnant or planning to become pregnant
- History of major abdominal surgery
- History of severe mental illness
- Total knee-replacement surgery or above-the-knee amputation
Show all 12Show fewer
- Any unstable or uncontrolled medical disorders
- Current use of proton pump inhibitors, anti-nausea medications, or other functional dyspepsia treatments UNLESS regimen has remained unchanged and stable over last 3 months
- Current use of anti-depressants or NSAIDs
- Having any implanted electrical devices (pacemakers, defibrillators, neurostimulators, or any other implanted electrical devices).
- Not being fluent in English
- Having prior significant experience/knowledge with acupuncture
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
MetroHealth Medical Center
Cleveland, Ohio, 44109
Donovan Veccia, 216-924-6246, dveccia@metrohealth.org
MetroHealth Parma Medical Center
Parma, Ohio, 44130
Donovan Veccia, 216-924-6246, dveccia@metrohealth.org
About this study
Official title: Transcutaneous Electrical Acustimulation Synchronized With Natural Breathing for Epigastric Pain Syndrome
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.
- Conditions
- Epigastric Pain Syndrome
- Being tested
- AutoSTEA device, Sham treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AutoSTEA deviceDevice
The AutoSTEA device is a device that detects the user's respiration wave and synchronizes each breath to deliver electrical stimulation at acupuncture points via skin surface electrodes. With this automated synchronization device, patients can inhale and exhale with an uninterrupted and normal respiration pace while receiving the TEA treatment, largely simplifying the treatment procedures, improving patients' compliance, and enhancing the effectiveness of the method.
Sham treatmentDevice
The sham treatment is the same as the AutoSTEA device except that it doesn't synchronize with users breathing. It still does deliver the same electric shocks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment First Arm | Other | This arm will receive the experimental treatment for 4 weeks. Receives: Device: AutoSTEA device |
| Sham first arm | Other | This arm will first receive the sham treatment for 4 weeks. Receives: Device: Sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's Symptom Response to the Treatment as Assessed by Functional Dyspepsia Symptom Diary
This 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 four weeks
Patient's Symptom Response to the Treatment as Assessed by Nepean Dyspepsia Index Questionnaire
Assess how well a patient's dyspepsia symptoms respond to the treatment. This will be done using the Nepean Dyspepsia Index Questionnaire. 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 4 being extreme effect on their daily lives.
Measured: From enrollment until the end of treatment at 4 weeks
Patient's Operating Experience with the Device as Assessed by Usability and Comfort Questionnaire
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 how easy and comfortable the device was to use. 0 would signify the device being extremely difficult and extremely uncomfortable to use, while 5 would signify the device being extremely easy and extremely comfortable to use.
Measured: From enrollment to the end of treatment in four weeks
Patient's Operating Experience with the Device when Self-Administered at Home as Assessed by the Weekly Safety and Adverse Events Questionnaire
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 be 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 no experienced adverse event and 5 being extremely severe (requiring medical attention).
Measured: From enrollment to the end of treatment in four weeks
Secondary outcomes (3)
Assess Patient Compliance with Device as Assessed by Daily Device-Use Log
Patients will keep a device-use log that is filled out daily. They will write how many sessions they use the device for and how long each session was.
Measured: From enrollment to the end of treatment in four weeks
Electrogastrogram (EGG) Measure
The patient will undergo an EGG. The myoelectrical activity of the stomach will be measured by cycles per minute (CPM), which is the frequency of electrical slow waves generated by the smooth muscles of the stomach. A CPM of under 2.5 or above 3.75 will be considered abnormal.
Measured: Once during the initial visit and once during the final visit (weeks 0 and 4).
Electrocardiogram (ECG) Measure
Patients will undergo an ECG. This will measure their heart rate variability (HRV) by tracking the interval in milliseconds between each heartbeat. What is considered normal or abnormal will vary greatly depending on the patient.
Measured: Once during the initial visit and once during the final visit (weeks 0 and 4).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epigastric Pain SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917598
- Sponsor's protocol ID
- STUDY00000910
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Acustimulation Synchronized With Natural Breathing for Epigastric Pain Syndrome
- ClinicalTrials.gov ID
- NCT07917598
- Acronym / sponsor ID
- STUDY00000910
- Conditions
- Epigastric Pain Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jul 2030 (estimated)
- First posted
- 4 Nov 2026 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment First Arm | Other | Device: AutoSTEA deviceThis arm will receive the experimental treatment for 4 weeks. |
| Sham first arm | Other | Device: Sham treatmentThis arm will first receive the sham treatment for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years of age
- Diagnosed with epigastric pain syndrome according to Rome V Criteria
- Experienced epigastric pain at least 3 days a week for at least 3 months
- Must have normal esophagogastroduodenoscopy performed in last 2 years
Key exclusion criteria (12 listed)
- Any history of gastritis, gastric/duodenal ulcers, or other organic upper GI diseases
- Current drug or alcohol abuse
- Currently pregnant or planning to become pregnant
- History of major abdominal surgery
- History of severe mental illness
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 |
|---|---|---|
| AutoSTEA deviceThe AutoSTEA device is a device that detects the user's respiration wave and synchronizes each breath to deliver electrical stimulation at acupuncture points via skin surface electrodes. With this automated synchronization device, patients can inhale and exhale with an uninterrupted and normal respiration pace while receiving the TEA treatment, largely simplifying the treatment procedures, improving patients' compliance, and enhancing the effectiveness of the method. | Device | Treatment First Arm |
| Sham treatmentThe sham treatment is the same as the AutoSTEA device except that it doesn't synchronize with users breathing. It still does deliver the same electric shocks. | Device | Sham first arm |
Primary outcome
Patient's Symptom Response to the Treatment as Assessed by Functional Dyspepsia Symptom Diary
Time frame: From enrollment to the end of treatment in four weeks
This 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.
Patient's Symptom Response to the Treatment as Assessed by Nepean Dyspepsia Index Questionnaire
Time frame: From enrollment until the end of treatment at 4 weeks
Assess how well a patient's dyspepsia symptoms respond to the treatment. This will be done using the Nepean Dyspepsia Index Questionnaire. 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 4 being extreme effect on their daily lives.
Patient's Operating Experience with the Device as Assessed by Usability and Comfort Questionnaire
Time frame: From enrollment to the end of treatment in four 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 how easy and comfortable the device was to use. 0 would signify the device being extremely difficult and extremely uncomfortable to use, while 5 would signify the device being extremely easy and extremely comfortable to use.
Patient's Operating Experience with the Device when Self-Administered at Home as Assessed by the Weekly Safety and Adverse Events Questionnaire
Time frame: From enrollment to the end of treatment in four 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 be 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 no experienced adverse event and 5 being extremely severe (requiring medical attention).
3 secondary outcomes
Assess Patient Compliance with Device as Assessed by Daily Device-Use Log
Time frame: From enrollment to the end of treatment in four weeks
Electrogastrogram (EGG) Measure
Time frame: Once during the initial visit and once during the final visit (weeks 0 and 4).
Electrocardiogram (ECG) Measure
Time frame: Once during the initial visit and once during the final visit (weeks 0 and 4).
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 4 Nov 2026.
- Individual participant dataSharing planned: No
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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.
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 AutoSTEA device in people with Epigastric Pain Syndrome, 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 4 inclusion and 12 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: opening soon, as of the sponsor's last update on 4 Nov 2026. 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?
Contact Donovan Veccia (2167783567, dveccia@metrohealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's Symptom Response to the Treatment as Assessed by Functional Dyspepsia Symptom Diary (time frame: From enrollment to the end of treatment in four weeks). The study lists 4 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 4 Nov 2026.