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NCT07020416 · ClinicalTrials.gov registry record · Phase 1
AutoSTEA for Adults With Functional Dyspepsia
A Phase 1 study of Functional Dyspepsia, sponsored by MetroHealth Medical Center.
- Active
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 2
- Study locations
NCT07020416: Active Phase 1 study of Functional Dyspepsia, sponsored by MetroHealth Medical Center.
NCT07020416 is a Phase 1 study of Functional Dyspepsia that is active but no longer recruiting, run by MetroHealth Medical Center. The registered enrollment target is 20 participants, below the 71-participant average among 9 other Functional Dyspepsia trials with a reported enrollment target (72% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07020416, a Phase 1 study of Functional Dyspepsia, is active but no longer recruiting, sponsored by MetroHealth Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 2
- Study locations
Study 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. 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Transcutaneous electrical acustimulation in automatic synchronization with breathing
Study Locations (2)
Ohio
- MetroHealth Medical Center - Main Campus - Cleveland
- MetroHealth Parma Medical Center - Parma
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-02-26 |
| Est. Completion | 2027-02 |
| Phase | Phase 1 |
What the registry record for NCT07020416 still lists
NCT07020416 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 71-participant average among 9 other Functional Dyspepsia trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Functional Dyspepsia appearing as the primary indexed condition, and to 1 intervention - of which Transcutaneous electrical acustimulation in automatic synchronization with breathing is the first listed.
NCT07020416 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT07020416 about?
NCT07020416 is a clinical study titled "AutoSTEA for Adults With Functional Dyspepsia". 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?...
What is the current status of trial NCT07020416?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2025-02-26. Estimated completion is 2027-02.
What conditions does trial NCT07020416 study?
This clinical trial studies the following conditions: Functional Dyspepsia.
What interventions are being tested in trial NCT07020416?
The interventions under investigation include: Transcutaneous electrical acustimulation in automatic synchronization with breathing (DEVICE).
Who is sponsoring clinical trial NCT07020416?
This trial is sponsored by MetroHealth Medical Center, which has 76 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07020416 being conducted?
This trial has 2 study locations across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Functional Dyspepsia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07020416's enrollment target sits among peer trials
20 9th of 9 higher than 1 of 9 other Functional Dyspepsia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Functional Dyspepsia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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