Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-17 @ 1:42 PM
Ignite Modification Date:
2025-12-22 @ 12:34 PM
NCT ID:
NCT07201961
Eligibility Criteria:
Inclusion Criteria:
1. Male or female participants ≥ 18 years of age, and \< 51 years of age.
2. Participant is willing and able to comply with study procedures and duration.
3. Participant is willing to sign an ICF.
4. Participant weighs \> 40kg (88.2 lb).
5. Participant is a non-smoker or has not smoked within 36 hours prior to the study.
6. Cleared same day health assessment form and health screening
7. Successful perfusion index ulnar/ulnar+radial ratio test (Assessed via the Allen's Test) showing adequate collateral blood flow.
Exclusion Criteria:
1. Participant is considered as being morbidly obese (defined as BMI \>39.5).
2. Compromised circulation, injury, or physical malformation of fingers, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the sites utilized)
3. Participants of childbearing potential who are pregnant, who are trying to get pregnant, or who have a urine test positive for pregnancy on the day of the study.
4. Subjects with COHb levels \>3% as assessed by CO-Oximetry during the procedure
5. tHb \< 10 g/dl as assessed by CO-Oximetry during the procedure
6. MetHb ≥ 2% as assessed by CO-Oximetry during the procedure
7. Participants with known respiratory conditions such as:
1. uncontrolled / severe asthma
2. flu or influenza type infection
3. pneumonia / bronchitis
4. shortness of breath / respiratory distress
5. unresolved respiratory or lung surgery
6. emphysema, COPD, lung disease
7. recent COVID (last 2 months)
8. Participants with known heart or cardiovascular conditions such as:
1. Uncontrolled hypertension (systolic pressure \>140mmHg, or diastolic pressure \>90mmHg on 3 consecutive readings day of screening)
2. previous cardiovascular surgery
3. chest pain (angina)
4. heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia (reviewed during health screen)
5. previous heart attack
6. blocked artery
7. unexplained shortness of breath
8. congestive heart failure (CHF)
9. history of stroke and/or transient ischemic attack
10. carotid artery disease
11. myocardial ischemia
12. myocardial infarction
13. cardiomyopathy
14. implantable active medical device such as pacemaker or automatic defibrillator
9. Self-reported health conditions as identified in the Health Assessment Form:
1. Diabetes
2. uncontrolled thyroid disease
3. kidney disease / chronic renal impairment
4. history of seizures (except childhood febrile seizures)
5. epilepsy
6. history of unexplained syncope
7. recent history of frequent migraine headaches (within the last 2 months)
8. recent symptomatic head injury (within the last 2 months)
9. cancer requiring chemotherapy, radiation, or current treatment
10. participants with known clotting disorders
11. history of bleeding disorders or personal history of prolonged bleeding from injury
12. history of blood clots
13. hemophilia
14. sickle cell trait or disease
15. current use of blood thinner: prescription or daily use of aspirin
16. participants with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors
17. participants with severe allergy to iodine (only applicable if iodine is used)
18. participants with prior or known severe allergies to lidocaine (or similar pharmacological agents, e.g. Novocain) or heparin
19. arterial cannulation within the last 30 days prior to study date, (this may exclude only one radial artery site, left or right)
20. history of clinically significant complications from previous arterial cannulation
21. unwillingness or inability to remove colored nail polish or colored artificial nails other than clear from test digits
22. other known health condition, upon disclosure in Health Assessment form
10. Failure of the Allen's Test.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
51 Years
Study:
NCT07201961
Study Brief:
Protocol Section:
NCT07201961