A Phase 1 interventional study of AutoSTEA device and Sham treatment in Epigastric Pain Syndrome, sponsored by MetroHealth Medical Center. Not yet recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by MetroHealth Medical Center · Phase 1, Interventional, and Treatment
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:
Participants will:
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 40 is below the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →MetroHealth Medical Center is the lead sponsor of 104 studies on the registry; 20 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 7 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
This arm will receive the experimental treatment for 4 weeks.
Device: AutoSTEA device
This arm will first receive the sham treatment for 4 weeks.
Device: Sham treatment
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: From enrollment to the end of treatment in four weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: Once during the initial visit and once during the final visit (weeks 0 and 4).
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Jan 2030, 36 months later.
Of 117 non-industry phase 1 interventional studies under Pain, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 45. This study's planned 36 months is above that.
Counting every sponsor, half of 221 studies reached it within 9 months; a quarter within 3 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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