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Breath Analysis for Detecting Fasting Status (Fast Breath Trial)

N/A

Waitlist Available

Led By Kenneth K Wang, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult (18+) patient undergoing scheduled elective outpatient upper endoscopy

Be older than 18 years old

Must not have

< 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new way to see if someone is fasting or not, by using a non-invasive and low-risk method, for people who are scheduled for a routine endoscopy.

Who is the study for?

This trial is for adults over 18 who are scheduled for an elective outpatient upper endoscopy. Participants must be able to breathe into the Aeonose device with a nose-plug before and after their procedure, follow standard fasting instructions, and consume refreshments post-procedure. It's not suitable for those unable to tolerate the breathing device or unwilling to consent.

What is being tested?

The study is testing the use of an electronic 'nose', known as Aeonose, which analyzes breath samples to distinguish between fasting and non-fasting states in patients undergoing routine endoscopy without any risk involved.

What are the potential side effects?

There are no risks or side effects associated with this trial since it involves only breath analysis using the Aeonose device; however, individuals with conditions like claustrophobia may find it uncomfortable.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am an adult scheduled for an outpatient upper endoscopy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: fasting breath analysisExperimental Treatment2 Interventions

Individuals consenting to participation of this study will be asked to provide a breath analysis using the Aeonose. Following their scheduled standard of care endoscopic procedure the patient will repeat the breath analysis

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aeonose

2020

N/A

~3790

0 / 2Eligibility criteria met