DyspepsiaNCT06941545
High Resolution Gastric Mapping and Gastroduodenal Manometry
A study testing Alimetry, tVNS and Gastroduodenal Manometry in people with Dyspepsia, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dyspepsia
- What is being tested?
- Alimetry, tVNS and Gastroduodenal Manometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptoms consistent with functional dyspepsia as defined by the ROME IV criteria for 6 months
- Ability to perform appropriate informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Nicholas R Oblizajek, MD
About this study
Official title: 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.
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
- Being tested
- Alimetry, tVNS, Gastroduodenal Manometry
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlimetryDevice
High resolution gastric mapping of electrical gastric activity.
tVNSDevice
Transcutaneous Auricular Vagal Nerve Stimulation, electrical stimulation to the ear.
Gastroduodenal ManometryDevice
Pressure catheter evaluating gastric and duodenal pressure profiles at rest and with certain stimuli applied
| Study group | Role | What they receive |
|---|---|---|
| Dyspeptic Patients undergoing clinically indicated gastroduodenal manometry study | Experimental | First arm evaluating patients undergoing clinically indicated gastroduodenal manometry evaluation with concurrent body surface gastric mapping (BSGM), with taVNS applied during the studies. Receives: Device: Alimetry; Device: tVNS; Device: Gastroduodenal Manometry |
| Dyspeptic patients not undergoing GDM, tested with body surface gastric mapping alone | Experimental | 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. Receives: Device: Alimetry; Device: tVNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal Antral and Duodenal Contraction Frequency
Summarized as frequency (number of contractions per minute)
Measured: During gastrointestinal motility study (approx. 8 hours)
Gastrointestinal Antral and Duodenal Contraction Amplitude
Summarized as amplitude (strength of contractions)
Measured: During gastrointestinal motility study (approx. 8 hours)
Gastrointestinal Antral and Duodenal Phasic Pressure Activity - Motility Index
Composite measure combining frequency and amplitude for overall assessment of motility
Measured: During gastrointestinal motility study (approx. 8 hours)
Principal Gastric Frequency
Dominant frequency of gastric waves (cycles per minute)
Measured: During gastrointestinal motility study (8 hours)
BMI-Adjusted Amplitude
Amplitude of the gastric myoelectrical signals adjusted for body mass index
Measured: During gastrointestinal motility study (8 hours)
Gastric Alimetry Rhythm Index (TM)
Concentration of power within the gastric frequency band over time, stability of gastric rhythm
Measured: During gastrointestinal motility study (8 hours)
Fed:Fasted Amplitude Ratio
Ratio compares the amplitude of gastric myoelectrical activity in the fed state to the fasting state, reflecting gastric response to a meal
Measured: During gastrointestinal motility study (8 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start11 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicholas Oblizajek, Mayo Clinic
- Investigators
- Nicholas R Oblizajek, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06941545
- Sponsor's protocol ID
- 25-000214
- Status last verified
- Sep 2026
- First submitted
- 9 Apr 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06941545
- Acronym / sponsor ID
- 25-000214
- Conditions
- Dyspepsia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 11 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dyspeptic Patients undergoing clinically indicated gastroduodenal manometry study | Experimental | Device: Alimetry, Device: tVNS, Device: Gastroduodenal ManometryFirst arm evaluating patients undergoing clinically indicated gastroduodenal manometry evaluation with concurrent body surface gastric mapping (BSGM), with taVNS applied during the studies. |
| Dyspeptic patients not undergoing GDM, tested with body surface gastric mapping alone | Experimental | Device: Alimetry, Device: tVNSParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Symptoms consistent with functional dyspepsia as defined by the ROME IV criteria for 6 months
- Ability to perform appropriate informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlimetryHigh resolution gastric mapping of electrical gastric activity. | Device | Dyspeptic Patients undergoing clinically indicated gastroduodenal manometry study, Dyspeptic patients not undergoing GDM, tested with body surface gastric mapping alone |
| tVNSTranscutaneous Auricular Vagal Nerve Stimulation, electrical stimulation to the ear. | Device | Dyspeptic Patients undergoing clinically indicated gastroduodenal manometry study, Dyspeptic patients not undergoing GDM, tested with body surface gastric mapping alone |
| Gastroduodenal ManometryPressure catheter evaluating gastric and duodenal pressure profiles at rest and with certain stimuli applied | Device | Dyspeptic Patients undergoing clinically indicated gastroduodenal manometry study |
Primary outcome
Gastrointestinal Antral and Duodenal Contraction Frequency
Time frame: During gastrointestinal motility study (approx. 8 hours)
Summarized as frequency (number of contractions per minute)
Gastrointestinal Antral and Duodenal Contraction Amplitude
Time frame: During gastrointestinal motility study (approx. 8 hours)
Summarized as amplitude (strength of contractions)
Gastrointestinal Antral and Duodenal Phasic Pressure Activity - Motility Index
Time frame: During gastrointestinal motility study (approx. 8 hours)
Composite measure combining frequency and amplitude for overall assessment of motility
Principal Gastric Frequency
Time frame: During gastrointestinal motility study (8 hours)
Dominant frequency of gastric waves (cycles per minute)
BMI-Adjusted Amplitude
Time frame: During gastrointestinal motility study (8 hours)
Amplitude of the gastric myoelectrical signals adjusted for body mass index
Gastric Alimetry Rhythm Index (TM)
Time frame: During gastrointestinal motility study (8 hours)
Concentration of power within the gastric frequency band over time, stability of gastric rhythm
Fed:Fasted Amplitude Ratio
Time frame: During gastrointestinal motility study (8 hours)
Ratio compares the amplitude of gastric myoelectrical activity in the fed state to the fasting state, reflecting gastric response to a meal
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Dyspepsia
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
RecruitingPhase 4
Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia
Functional Dyspepsia, Probiotics
RecruitingPhase 2
Exploring Novel Therapeutic Approaches for Disorders of Gut-Liver-Brain Interaction-H1/H2
Functional Gastrointestinal Disorders
Not yet recruitingObservational study
Interactive Effects of Early-Life Stress, Diet, and Metabolism on Gastrointestinal Dysfunction With Neuropsychiatric Symptoms
Irritable Bowel Syndrome (IBS), Functional Dyspepsia
Active, not recruitingObservational study
Evaluation of the SIMBA Capsule for Small Intestinal Dysbiosis
Irritable Bowel Syndrome, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicholas R Oblizajek, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alimetry, tVNS and Gastroduodenal Manometry in people with Dyspepsia, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shelly L Ward (507-538-9997, Ward.Shelly1@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal Antral and Duodenal Contraction Frequency (time frame: During gastrointestinal motility study (approx. 8 hours)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.