Electronic Nose Identification of Fasting and Non-fasting Breath Profiles
Overview
Tab Title Description
Study type
InterventionalDescribes 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.
Study IDs
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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Adult (18+) patient undergoing scheduled elective outpatient upper endoscopy.
- Willing and able to consent to research protocol.
- Fasting as required per routine instruction for upper endoscopy.
- Able to breath for approximately 10 minutes pre and post procedure into the Aeonose device with a nose-plug on.
- Able to consume standard refreshments post procedure during recovery per routine endoscopic area policy.
Exclusion Criteria:
- Non-fasting per protocol, or known to have had food or drink outside of routine protocol.
- Non-English speaking.
- < 18 years of age.
- Unable or unwilling to consent to research protocol.
- Inability to tolerate Aeonose breathing (such as those with claustrophobia, anxiety, nasal trauma, etc.).
- Use of antibiotics or systemic immunosuppressants within three months prior to the date of endoscopy (intranasal and inhaled steroids are allowed).
- Any prior chemotherapy for esophageal cancer
- History of squamous cell carcinoma.
- History of gastric or esophageal surgery.
- Per PI discretion, any current medical problem that could alter intended study data collection.
Eligibility last updated 3/25/22. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Cadman Leggett, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available