A Study to Evaluate Endoflip Normal Ranges Data in Healthy Volunteers

Completed

• Conditions: Healthy
• Interventions: Diagnostic Test: Endoflip measurement of gastric and pyloric function

• Registration Number: NCT04809883
• Lead Sponsor: Mayo Clinic

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

Study Timeline

• Study First Submitted: 2021-03-02
• Study Start: 2021-03-06
• Study First Submitted QC: 2021-03-19
• Study First Posted: 2021-03-22
• Primary Completion: 2021-06-23
• Study Completion: 2021-06-23
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-25
• Last Update Posted: 2022-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
observational study of gastric and pyloric motor function measured with Endoflip	Endoflip measurement of gastric and pyloric function	observational study of gastric and pyloric motor function measured with Endoflip during fasting and postprandial periods There is NO intervention

Primary Outcome Measures

Name	Time	Method
fasting and postprandial pyloric diameter	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	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	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

Trial Locations

Locations (1)

Michael Camilleri; 🇺🇸 Rochester, Minnesota, United States