Breath Analysis for Detecting Fasting Status

(Fast Breath Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Non-fasting, < 18 years, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

879 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators will study a noninvasive no risk process by which the investigators can quickly screen and assess for fasting and non-fasting states in individuals scheduled for routine endoscopy.

Research Team

Cadman Leggett, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Inclusion Criteria

Fasting as required per routine instruction for upper endoscopy

Willing and able to consent to research protocol

I am an adult scheduled for an outpatient upper endoscopy.

Exclusion Criteria

I am under 18 years old.

You cannot use the Aeonose breathing device due to reasons like feeling claustrophobic, anxious, or having a nasal injury.

Non-fasting per protocol, or known to have had food or drink outside of routine protocol

Treatment Details

Interventions

• Aeonose

Trial Overview 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.

Participant Groups

Group I: fasting breath analysis Experimental Treatment 2 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

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+