High Resolution Gastric Mapping and Gastroduodenal Manometry

NCT ID: NCT06941545

Last Updated: 2025-08-19

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-11

Study Completion Date

2026-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Dyspepsia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

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.

Group Type EXPERIMENTAL

Alimetry

Intervention Type DEVICE

High resolution gastric mapping of electrical gastric activity.

tVNS

Intervention Type DEVICE

Transcutaneous Auricular Vagal Nerve Stimulation, electrical stimulation to the ear.

Gastroduodenal Manometry

Intervention Type DEVICE

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.

Group Type EXPERIMENTAL

Alimetry

Intervention Type DEVICE

High resolution gastric mapping of electrical gastric activity.

tVNS

Intervention Type DEVICE

Transcutaneous Auricular Vagal Nerve Stimulation, electrical stimulation to the ear.

Interventions

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Alimetry

High resolution gastric mapping of electrical gastric activity.

Intervention Type DEVICE

tVNS

Transcutaneous Auricular Vagal Nerve Stimulation, electrical stimulation to the ear.

Intervention Type DEVICE

Gastroduodenal Manometry

Pressure catheter evaluating gastric and duodenal pressure profiles at rest and with certain stimuli applied

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Nicholas Oblizajek

Principal Investigator

Responsibility Role 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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Shelly L Ward

Role: CONTACT

507-538-9997

Related Links

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Other Identifiers

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25-000214

Identifier Type: -

Identifier Source: org_study_id

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