NCT06941545 High Resolution Gastric Mapping and Gastroduodenal Manometry
| NCT ID | NCT06941545 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Dyspepsia |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-07-11 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-07-11 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
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
Contact & Investigator
Nicholas R Oblizajek, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT06941545 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Dyspepsia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06941545 currently recruiting?
Yes, NCT06941545 is actively recruiting participants. Contact the research team at Ward.Shelly1@mayo.edu for enrollment information.
Where is the NCT06941545 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT06941545 clinical trial?
NCT06941545 is sponsored by Mayo Clinic. The principal investigator is Nicholas R Oblizajek, MD at Mayo Clinic. The trial plans to enroll 100 participants.