High Resolution Gastric Mapping and Gastroduodenal Manometry
NCT ID: NCT06941545
Last Updated: 2025-08-19
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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RECRUITING
NA
100 participants
INTERVENTIONAL
2025-07-11
2026-12-31
Brief Summary
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The purpose of this research is to identify disturbances and characterize phenotypes in patients with functional dyspepsia, and to assess the correlations between symptoms (during the manometry and in daily life), gastric emptying, electrical activity (BSGM), and pressure activity (manometry).
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Dyspeptic Patients undergoing clinically indicated gastroduodenal manometry study
First arm evaluating patients undergoing clinically indicated gastroduodenal manometry evaluation with concurrent body surface gastric mapping (BSGM), with taVNS applied during the studies.
Alimetry
High resolution gastric mapping of electrical gastric activity.
tVNS
Transcutaneous Auricular Vagal Nerve Stimulation, electrical stimulation to the ear.
Gastroduodenal Manometry
Pressure catheter evaluating gastric and duodenal pressure profiles at rest and with certain stimuli applied
Dyspeptic patients not undergoing GDM, tested with body surface gastric mapping alone
Participants who have been seen in the clinical setting, having undergone other clinically indicated testing, will be recruited to undergo body surface gastric mapping (BSGM). At the end of the protocolized BSGM study the patient will undergo taVNS intervention.
Alimetry
High resolution gastric mapping of electrical gastric activity.
tVNS
Transcutaneous Auricular Vagal Nerve Stimulation, electrical stimulation to the ear.
Interventions
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Alimetry
High resolution gastric mapping of electrical gastric activity.
tVNS
Transcutaneous Auricular Vagal Nerve Stimulation, electrical stimulation to the ear.
Gastroduodenal Manometry
Pressure catheter evaluating gastric and duodenal pressure profiles at rest and with certain stimuli applied
Eligibility Criteria
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Inclusion Criteria
* Ability to perform appropriate informed consent
Exclusion Criteria
* Conditions precluding safe use of taVNS
* Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns
* Use of opioids
* Vulnerable study population
* Pregnant women
18 Years
80 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Nicholas Oblizajek
Principal Investigator
Principal Investigators
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Nicholas R Oblizajek, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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25-000214
Identifier Type: -
Identifier Source: org_study_id
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