A Study to Evaluate Endoflip Normal Ranges Data in Healthy Volunteers

April 25, 2022 updated by: Michael Camilleri, MD, Mayo Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Michael Camilleri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

healthy adults between the ages of 18 and 65 with body mass indices between 18 and 35 kilograms/meter squared will be recruited for this study

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
observational study of gastric and pyloric motor function measured with Endoflip
observational study of gastric and pyloric motor function measured with Endoflip during fasting and postprandial periods There is NO intervention
Diagnostic test: Endoflip measurement of gastric and pyloric function
Endoflip device to measure gastric and pyloric functions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 hour prior to meal and 1 hour following standardized meal
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
1 hour prior to meal and 1 hour following standardized meal
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
1 hour prior to meal and 1 hour following standardized meal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2021

Primary Completion (Actual)

June 23, 2021

Study Completion (Actual)

June 23, 2021

Study Registration Dates

First Submitted

March 2, 2021

First Submitted That Met QC Criteria

March 19, 2021

First Posted (Actual)

March 22, 2021

Study Record Updates

Last Update Posted (Actual)

April 27, 2022

Last Update Submitted That Met QC Criteria

April 25, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 20-012285

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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