High Resolution Gastric Mapping and Gastroduodenal Manometry

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT06941545
Status
Recruiting
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Conditions

  • Dyspepsia

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

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

Study Details

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).

Key Dates

Start date
Jul 11, 2025
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

Gastrointestinal Antral and Duodenal Contraction Frequency [ Time Frame: During gastrointestinal motility study (approx. 8 hours) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Nicholas R Oblizajek, MD (PRINCIPAL_INVESTIGATOR)

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Mayo Clinic in Rochester· Rochester, MN

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