A Study to Evaluate Endoflip Normal Ranges Data in Healthy Volunteers

NCT04809883 | Completed FDA Device

• 1 other identifier: 20-012285
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• fasting and postprandial pyloric diameter

  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

  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

  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

Study Arms (1)

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

Interventions

Endoflip measurement of gastric and pyloric function DIAGNOSTIC_TEST

Endoflip device to measure gastric and pyloric functions

observational study of gastric and pyloric motor function measured with Endoflip

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: equal number of males and females will be recruited for this study in up to 45 adults
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Michael Camilleri

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Michael Camilleri, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 22, 2021
• Study Start: March 6, 2021
• Primary Completion: June 23, 2021
• Study Completion: June 23, 2021
• Last Updated: April 27, 2022

Record last verified: 2022-04

Locations

US (1)