Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
20 participants
INTERVENTIONAL
2025-02-26
2027-02-28
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Adult patients with functional dyspepsia
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.
Transcutaneous electrical acustimulation in automatic synchronization with breathing
This intervention will be carried out via the AutoSTEA device.
Interventions
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Transcutaneous electrical acustimulation in automatic synchronization with breathing
This intervention will be carried out via the AutoSTEA device.
Eligibility Criteria
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Inclusion Criteria
* Must meet Rome IV criteria for functional dyspepsia
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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MetroHealth Medical Center
OTHER
Responsible Party
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Principal Investigators
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Michael Kurin, MD
Role: PRINCIPAL_INVESTIGATOR
MetroHealth Medical Center
Locations
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MetroHealth Medical Center - Main Campus
Cleveland, Ohio, United States
MetroHealth Parma Medical Center
Parma, Ohio, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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STUDY00000169
Identifier Type: -
Identifier Source: org_study_id
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