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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to verify fasting before routine endoscopy using a simple breath test. The test employs a device called Aeonose, a breath analysis tool, and is completely noninvasive, requiring no needles or medical instruments. It suits adults already fasting for their scheduled endoscopy, who can breathe into the device for about 10 minutes before and after the procedure. Participants must be comfortable wearing a nose plug during the test and able to have refreshments afterward. This approach could simplify ensuring patients are ready for their procedure. As an unphased trial, this study allows participants to contribute to innovative research that may streamline pre-procedure preparations for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on fasting and breathing tests related to endoscopy.

What prior data suggests that the Aeonose is safe for breath analysis?

Research has shown that the Aeonose device is a safe and non-invasive tool for analyzing breath. Studies have used it to help detect diseases like lung and colon cancer, demonstrating its versatility and low risk. The Aeonose examines the components in a person's breath without requiring invasive procedures. Results suggest it is well-tolerated with no known side effects. Additionally, since this study is not in a clinical trial phase, the device has already demonstrated a high level of safety in previous uses. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the breath analysis using the Aeonose because it offers a non-invasive way to detect fasting status. Unlike traditional methods that might involve blood tests or patient questionnaires, the Aeonose analyzes a simple breath sample, making it quicker and easier for patients. This new approach could streamline how we prepare patients for procedures that require fasting, potentially improving both efficiency and patient comfort.

What evidence suggests that the Aeonose is effective for detecting fasting status?

Research has shown that electronic nose devices, such as the Aeonose, are promising tools for analyzing breath. These devices have successfully identified conditions like lung cancer by detecting unique chemical markers in breath. In this trial, participants will undergo breath analysis using the Aeonose to determine if it can identify fasting status by analyzing breath odors to distinguish between fasting and non-fasting states. Although specific data on detecting fasting is limited, the success of electronic noses in other areas suggests potential effectiveness. ^{1 6 7 8 9}

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+

Citations

1. nature.com nature.com/articles/s41378-023-00594-0

Research progress of electronic nose technology in ... This review is intended to provide an overview of the application of human exhaled breath components in disease diagnosis, existing breath testing technologies.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02419976

Electronic Nose Identification of Fasting and Non ... Electronically characterize what the human breath smells like during a non- fasting state, breath analysis obtained post endoscopic procedure (approximately 10 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12086828/

The electronic nose in lung cancer diagnostics Electronic nose devices show promise as fast and noninvasive point-of-care strategies for lung cancer diagnosis.

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/adsr.202300018

A Mobile E‐Nose Prototype for Online Breath Analysis An e-nose prototype is presented for online breath analysis with a specially designed sensor array and a gas storage chamber structure.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0010482520300937

Recognizing lung cancer using a homemade e-nose The proposed e-nose showed a comparable performance than many other reported e-nose systems in detecting lung cancer . Abstract. In recent years, breath ...

6. enose-company.com enose-company.com/en/

Clarity is a breath away With the aeoNose, we remove any barrier that stands in the way of early detection of diseases such as lung and colon cancer.

7. enose-company.com enose-company.com/en/disease/lung-cancer/

Lung cancer detection with aeoNose How safe is the exhaled-breath test with respect to personal data? All exhaled-breath tests are being processed in a way that preserves anonymity by encryption.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12238155/

Electronic-Nose Technology for Lung Cancer Detection Despite current limitations, E-nose technology shows strong potential as a rapid, non-invasive, and cost-effective tool for early LC screening.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10564766/

Research progress of electronic nose technology in ... This review is intended to provide an overview of the application of human exhaled breath components in disease diagnosis, existing breath testing technologies.