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A Study to Evaluate Endoflip Normal Ranges Data in Healthy Volunteers

Normative EndoFlip Data on the Diameter and Distensibility of the Pylorus During Fasting and Postprandially in Healthy Females and Male Adults

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04809883
Enrollment
30
Registered
2021-03-22
Start date
2021-03-06
Completion date
2021-06-23
Last updated
2022-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

The purpose of this research is to establish the normal range of diameter and distensibility of pylorus and the fasting and postprandial antro-pyloric motility in healthy adults.

Detailed description

An Endoflip catheter will be placed through the mouth into the stomach in order to measure distal antral contractile activity and pyloric diameter and distensibility during fasting and after the ingestion of a standard meal

Interventions

DIAGNOSTIC_TESTEndoflip measurement of gastric and pyloric function

Endoflip device to measure gastric and pyloric functions

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Females and males. * Between the ages of 18 and 65 years. * Body mass index between 18 and 35 kg/m\^2.

Exclusion criteria

* Heartburn, regurgitation, or symptoms suggestive of gastroparesis such as nausea, early satiety, postprandial bloating, and upper abdominal pain. * Pregnant

Design outcomes

Primary

MeasureTime frameDescription
fasting and postprandial pyloric diameter1 hour prior to meal and 1 hour following standardized mealChange in Pyloric diameter will be measured during fasting and postprandial using Endoflip
fasting and postprandial pyloric distensibility index1 hour prior to meal and 1 hour following standardized mealChange in Pyloric distensibility index will be measured during fasting and postprandial using Endoflip
fasting and postprandial distal antral motility index1 hour prior to meal and 1 hour following standardized mealChange in distal antral motility index will be measured during fasting and postprandial using Endoflip

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026