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OpenTrials
Completed

NCT Number: NCT04809883

A Study to Evaluate Endoflip Normal Ranges Data in Healthy Volunteers

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Michael Camilleri

Rochester, Minnesota, 55905, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoflip measurement of gastric and pyloric function

Diagnostic Test

Endoflip device to measure gastric and pyloric functions

Primary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 22, 2021
Registry last updated
Apr 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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