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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous electrical acustimulation in automatic synchronization with breathing | Device | This intervention will be carried out via the AutoSTEA device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | From enrollment to the end of treatment in two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment in two weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Kurin, MD | MetroHealth Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MetroHealth Medical Center - Main Campus | Cleveland | Ohio | 44109 | United States | ||
| MetroHealth Parma Medical Center |
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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 7, 2025 | Apr 25, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 14, 2025 | May 15, 2025 | SAP_001.pdf |
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| 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. |
| From enrollment to the end of treatment in two weeks |
| Parma |
| Ohio |
| 44130 |
| United States |