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Clinical Trials/NCT04809883
NCT04809883
Completed
Not Applicable

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

Mayo Clinic1 site in 1 country30 target enrollmentMarch 6, 2021
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
Mayo Clinic
Enrollment
30
Locations
1
Primary Endpoint
fasting and postprandial pyloric diameter
Status
Completed
Last Updated
4 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
March 6, 2021
End Date
June 23, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael Camilleri, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Outcomes

Primary Outcomes

fasting and postprandial pyloric diameter

Time Frame: 1 hour prior to meal and 1 hour following standardized meal

Change in Pyloric diameter will be measured during fasting and postprandial using Endoflip

fasting and postprandial pyloric distensibility index

Time Frame: 1 hour prior to meal and 1 hour following standardized meal

Change in Pyloric distensibility index will be measured during fasting and postprandial using Endoflip

fasting and postprandial distal antral motility index

Time Frame: 1 hour prior to meal and 1 hour following standardized meal

Change in distal antral motility index will be measured during fasting and postprandial using Endoflip

Study Sites (1)

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