HealthyNCT04809883
A Study to Evaluate Endoflip Normal Ranges Data in Healthy Volunteers
An observational study of Healthy, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Endoflip measurement of gastric and pyloric function
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2021to 23 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Females and males.
- Between the ages of 18 and 65 years.
- Body mass index between 18 and 35 kg/m^2.
Who cannot join
- Heartburn, regurgitation, or symptoms suggestive of gastroparesis such as nausea, early satiety, postprandial bloating, and upper abdominal pain.
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Healthy
- Being tested
- Endoflip measurement of gastric and pyloric function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoflip measurement of gastric and pyloric functionDiagnostic test
Endoflip device to measure gastric and pyloric functions
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Endoflip measurement of gastric and pyloric function |
What is being measured
The primary outcome is the main question the study is designed to answer.
fasting and postprandial pyloric diameter
Change in Pyloric diameter will be measured during fasting and postprandial using Endoflip
Measured: 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
Measured: 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
Measured: 1 hour prior to meal and 1 hour following standardized meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start6 Mar 2021
- Primary completion23 Jun 2021
- Study completion23 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Camilleri, MD, Mayo Clinic
- Investigators
- Michael Camilleri, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809883
- Sponsor's protocol ID
- 20-012285
- Status last verified
- Apr 2022
- First submitted
- 2 Mar 2021
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normative EndoFlip Data on the Diameter and Distensibility of the Pylorus During Fasting and Postprandially in Healthy Females and Male Adults
- ClinicalTrials.gov ID
- NCT04809883
- Acronym / sponsor ID
- 20-012285
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 6 Mar 2021 (actual)
- Primary completion
- 23 Jun 2021 (actual)
- Study completion
- 23 Jun 2021 (actual)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observational study of gastric and pyloric motor function measured with Endoflip | – | Diagnostic Test: Endoflip measurement of gastric and pyloric functionobservational study of gastric and pyloric motor function measured with Endoflip during fasting and postprandial periods There is NO intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Females and males.
- Between the ages of 18 and 65 years.
- Body mass index between 18 and 35 kg/m^2.
Key exclusion criteria (2 listed)
- Heartburn, regurgitation, or symptoms suggestive of gastroparesis such as nausea, early satiety, postprandial bloating, and upper abdominal pain.
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoflip measurement of gastric and pyloric functionEndoflip device to measure gastric and pyloric functions | Diagnostic test | observational study of gastric and pyloric motor function measured with Endoflip |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Camilleri, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fasting and postprandial pyloric diameter (time frame: 1 hour prior to meal and 1 hour following standardized meal). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022; AzTrials last refreshed its copy on 30 Oct 2026.