Electronic Nose Identification of Fasting and Non-fasting Breath Profiles

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 14-009226
    NCT ID: NCT02419976
    Sponsor Protocol Number: 14-009226

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  1. Adult (18+) patient undergoing scheduled elective outpatient upper endoscopy
  2. Willing and able to consent to research protocol
  3. Fasting as required per routine instruction for upper endoscopy
  4. Able to breath for approximately 10 minutes pre and post procedure into the Aeonose device with a nose-plug on
  5. Able to consume standard refreshments post procedure during recovery per routine endoscopic area policy

Exclusion Criteria:

  1. Non-fasting per protocol, or known to have had food or drink outside of routine protocol
  2. < 18 years of age
  3. Unable or unwilling to consent to research protocol
  4. Inability to tolerate Aeonose breathing (such as those with claustrophobia, anxiety, nasal trauma, etc.)
  5. Unable to consume refreshment post procedurally
  6. Unable to repeat Aeonose measurement post-procedurally due to tolerance or medical indication (such as instructed to remain fasting)

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kenneth Wang, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Bryan Linn

(507)284-6050

Linn.Bryan@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available