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: 2

879 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Cadman Leggett, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 can breathe through a device with a nose-plug for about 10 minutes.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Breath Analysis

Participants provide a breath analysis using the Aeonose before and after their scheduled endoscopic procedure

1 day

2 visits (in-person)

Follow-up

Participants are monitored for any sedation-related complications post-procedure

1 week

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+