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RECRUITING Not applicable ClinicalTrials.gov

High Resolution Gastric Mapping and Gastroduodenal Manometry

Sponsor: Mayo Clinic • ClinicalTrials.gov ID: NCT06941545

Registry updated: 2026-09-11
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Description

Dyspepsia is a common problem attributed to gastric sensorimotor dysfunctions ie, delayed, or less frequently rapid gastric emptying (GE), impaired gastric accommodation, and increased gastric sensation. Therapeutic options manage symptoms, and there is no FDA approved medical therapy for dyspepsia. There is a need for better objective understanding of sensorimotor dysfunction in dyspepsia, as well as noninvasive, efficacious, safe, and inexpensive treatments for dyspepsia. 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).

Interventions

  • Alimetry (Device)
    High resolution gastric mapping of electrical gastric activity.
  • tVNS (Device)
    Transcutaneous Auricular Vagal Nerve Stimulation, electrical stimulation to the ear.
  • Gastroduodenal Manometry (Device)
    Pressure catheter evaluating gastric and duodenal pressure profiles at rest and with certain stimuli applied

Eligibility criteria

Inclusion Criteria * Symptoms consistent with functional dyspepsia as defined by the ROME IV criteria for 6 months * Ability to perform appropriate informed consent Exclusion Criteria * Known cardiac arrhythmia or major ECG abnormalities, i.e. cardiac conduction disturbances (2nd or 3rd degree AV block, prolonged QTc interval (\> 460 msec) or bradycardia (\< 45 beats/minute) * 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

Conditions

Dyspepsia

Locations

  • Mayo Clinic in Rochester — Rochester, Minnesota, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record