Trial Outcomes & Findings for Electronic Nose Identification of Fasting and Non-fasting Breath Profiles (NCT NCT02419976)

NCT ID: NCT02419976

Last Updated: 2026-01-26

Results Overview

Exhaled Volatile Organic Compounds (VOCs) were collected by subject's breathing into a non-invasive breath analyzer (Aeonose) for 5 minutes by which through pattern recognition electronic changes can be identified in exhaled volatile organic compounds interfacing with an electronic sensor that creates an electronic signature, or smell-print that distinguishes the fasting and non-fasting states. The effectiveness of the Aeonose in distinguishing subjects in a fasting versus non-fasting state is represented by the device's sensitivity and specificity (ability to positively identify subjects who are in a fasting state versus non-fasting state).

Recruitment status

TERMINATED

Study phase

Target enrollment

879 participants

Primary outcome timeframe

breath analysis obtained (approximately 10 minutes procedure)

Results posted on

2026-01-26

Participant Flow

The protocol required classifying subjects as fasting or non-fasting, but only 185 fasting and 33 non-fasting subjects can be reported. As the data field in the study database designated to record fasting status was not implemented consistently throughout the study, fasting information was as a result not collected for the majority of enrolled subjects. The study team cannot retrospectively determine or report fasting status for the remaining subjects.

Participant milestones

Participant milestones
Measure	Fasting Breath Analysis 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 a breath analysis using the Aeonose: using the Aeonose per standard acquisition protocol which spans 15 minutes of which the individuals breaths normally through a sterile disposable mouthpiece with sterile disposable air filters for 5 minutes during signal acquisition while wearing a nose plug. This will be completed in the office setting prior to their endoscopic procedure. Following their scheduled standard of care endoscopic procedure the patient will be allowed to consume a standardized refreshment (such as juice or soda) prior to discharge from the post procedure area. These refreshments are already provided as standard care. The participant will return to the office setting and repeat the same breath analysis acquisition process that was done prior to the procedure. Aeonose
Overall Study STARTED	879
Overall Study Fasting	185
Overall Study Non-Fasting	33
Overall Study COMPLETED	879
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Electronic Nose Identification of Fasting and Non-fasting Breath Profiles

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fasting Breath Analysis n=879 Participants 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 a breath analysis using the Aeonose: using the Aeonose per standard acquisition protocol which spans 15 minutes of which the individuals breaths normally through a sterile disposable mouthpiece with sterile disposable air filters for 10 minutes during signal acquisition while wearing a nose plug. This will be completed in the office setting prior to their endoscopic procedure. Following their scheduled standard of care endoscopic procedure the patient will be allowed to consume a standardized refreshment (such as juice or soda) prior to discharge from the post procedure area. These refreshments are already provided as standard care. The participant will return to the office setting and repeat the same breath analysis acquisition process that was done prior to the procedure. Aeonose
Age, Categorical <=18 years	0 Participants n=25 Participants
Age, Categorical Between 18 and 65 years	456 Participants n=25 Participants
Age, Categorical >=65 years	423 Participants n=25 Participants
Age, Continuous	44 years n=25 Participants
Sex: Female, Male Female	331 Participants n=25 Participants
Sex: Female, Male Male	548 Participants n=25 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=25 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	780 Participants n=25 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	89 Participants n=25 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=25 Participants
Race (NIH/OMB) Asian	10 Participants n=25 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=25 Participants
Race (NIH/OMB) Black or African American	6 Participants n=25 Participants
Race (NIH/OMB) White	786 Participants n=25 Participants
Race (NIH/OMB) More than one race	0 Participants n=25 Participants
Race (NIH/OMB) Unknown or Not Reported	77 Participants n=25 Participants
Region of Enrollment United States	879 participants n=25 Participants

PRIMARY outcome

Timeframe: breath analysis obtained (approximately 10 minutes procedure)

Population: Due to loss of funding and the closure of the device provider, the study team was unable to obtain or access the device-generated data on 661 subjects. As a result, this data was never uploaded to the study database and cannot be retrieved.

Outcome measures

Outcome measures
Measure	Breath Analysis n=218 Participants 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 a breath analysis using the Aeonose: using the Aeonose per standard acquisition protocol which spans 15 minutes of which the individuals breaths normally through a sterile disposable mouthpiece with sterile disposable air filters for 5 minutes during signal acquisition while wearing a nose plug. This will be completed in the office setting prior to their endoscopic procedure. Following their scheduled standard of care endoscopic procedure the patient will be allowed to consume a standardized refreshment (such as juice or soda) prior to discharge from the post procedure area. These refreshments are already provided as standard care. The participant will return to the office setting and repeat the same breath analysis acquisition process that was done prior to the procedure. Aeonose
Effectiveness of the Aeonose in Distinguishing a Fasting Versus Non-fasting Breath Profile Sensitivity	194 Participants
Effectiveness of the Aeonose in Distinguishing a Fasting Versus Non-fasting Breath Profile Specificity	185 Participants
Effectiveness of the Aeonose in Distinguishing a Fasting Versus Non-fasting Breath Profile Accuracy	194 Participants
Effectiveness of the Aeonose in Distinguishing a Fasting Versus Non-fasting Breath Profile Positive Predictive Value	212 Participants
Effectiveness of the Aeonose in Distinguishing a Fasting Versus Non-fasting Breath Profile Negative Predictive Value	126 Participants

Adverse Events

Non Fasting Breath Analysis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kevin Buller

Mayo Clinic

Phone: 507-255-5476

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place