NCT06941545

High Resolution Gastric Mapping and Gastroduodenal Manometry

An Assessment of Gastrointestinal Function Utilizing High Resolution Gastric Mapping, Gastroduodenal Manometry, and Gastric Emptying Testing With Assessment of Acute Response to Transcutaneous Auricular Vagal Nerve Stimulation.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

• Dyspepsia

Interventions

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

Timeline

• Start date: 2025-07-11
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-04-23
• Last updated: 2025-08-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study