Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06941545

High Resolution Gastric Mapping and Gastroduodenal Manometry

Led by Mayo Clinic · Updated on 2025-08-19

100

Participants Needed

1

Research Sites

76 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

High Resolution Gastric Mapping and Gastroduodenal Manometry

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Symptoms consistent with functional dyspepsia as defined by the ROME IV criteria for 6 months
  • Ability to perform appropriate informed consent
Not Eligible

You will not qualify if you...

  • Known cardiac arrhythmia or major ECG abnormalities, including 2nd or 3rd degree AV block, prolonged QTc interval (> 460 msec), or bradycardia (< 45 beats/minute)
  • Conditions that prevent safe use of transcutaneous auricular vagal nerve stimulation (taVNS)
  • Significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other diseases that may interfere with study objectives or pose safety concerns
  • Use of opioids
  • Vulnerable study population
  • Pregnant women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

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Research Team

S

Shelly L Ward

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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