COMPLETED

Accuracy Performance Verification of the INVOS™ PM7100 System in Adults

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Prospective, observational, post-market, verification study to ensure compliance to the ISO 80601-2-85:2021 standard

Official Title

Accuracy Performance Verification of the INVOS™ PM7100 System by Comparing rSO2 Values to Reference Blood Oxygen Saturation Measurements in Adult Human Volunteers

Quick Facts

Study Start:2024-10-21

Study Completion:2025-07-22

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06581835

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. Subjects between the ages of 18 to 50 years 2. Completion of a health screening for medical history by a licensed physician, nurse practitioner, or physician assistant 3. Minimum weight 40kg 4. BMI within range 18.0 - 29.9	1. Prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., Novocain) \[self-reported\] 2. Prior known severe allergies to medical grade adhesive/tape (Band-Aid) \[self-reported\] 3. Subjects taking medication(s) beyond birth control may be excluded from participating at the PI discretion \[self-reported\] 4. Any interventional study within 30 days that, in the opinion of the PI, electrocardiogram (ECG) may interfere with study participation (i.e., drug, biologic) 5. Negative Allen's test for radial and ulnar patency 6. Has made a whole blood donation or has had at least 450 ml of blood drawn within 8 weeks prior to the study procedure \[self-reported\] 7. Is pregnant 8. Has anemia as measured by co-oximetry \[values specific for sex\] 9. Has a history of sickle cell trait or thalassemia \[self-reported\] 10. Has an abnormal hemoglobin electrophoresis test \[lab measurement\] 11. Has a positive urine cotinine test or urine drug screen or oral ethanol test \[Point of Care (POC) testing\] 12. Has a room air saturation less than 95% by pulse oximetry \[measurement by PI or delegate\] 13. Has a clinically significant abnormal ECG \[assessment by PI or delegate\] 14. Has a clinically significant abnormal pulmonary function test via spirometry \[assessment by PI or delegate\] 15. Has a COHb greater than 3%, or MetHb greater than 2% \[measured by venous blood sample co-oximetry\]

Inclusion Criteria

Exclusion Criteria

1. Subjects between the ages of 18 to 50 years
2. Completion of a health screening for medical history by a licensed physician, nurse practitioner, or physician assistant
3. Minimum weight 40kg
4. BMI within range 18.0 - 29.9

1. Prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., Novocain) \[self-reported\]
2. Prior known severe allergies to medical grade adhesive/tape (Band-Aid) \[self-reported\]
3. Subjects taking medication(s) beyond birth control may be excluded from participating at the PI discretion \[self-reported\]
4. Any interventional study within 30 days that, in the opinion of the PI, electrocardiogram (ECG) may interfere with study participation (i.e., drug, biologic)
5. Negative Allen's test for radial and ulnar patency
6. Has made a whole blood donation or has had at least 450 ml of blood drawn within 8 weeks prior to the study procedure \[self-reported\]
7. Is pregnant
8. Has anemia as measured by co-oximetry \[values specific for sex\]
9. Has a history of sickle cell trait or thalassemia \[self-reported\]
10. Has an abnormal hemoglobin electrophoresis test \[lab measurement\]
11. Has a positive urine cotinine test or urine drug screen or oral ethanol test \[Point of Care (POC) testing\]
12. Has a room air saturation less than 95% by pulse oximetry \[measurement by PI or delegate\]
13. Has a clinically significant abnormal ECG \[assessment by PI or delegate\]
14. Has a clinically significant abnormal pulmonary function test via spirometry \[assessment by PI or delegate\]
15. Has a COHb greater than 3%, or MetHb greater than 2% \[measured by venous blood sample co-oximetry\]

Contacts and Locations

Study Locations (Sites)

Duke University

Durham, North Carolina, 27705

United States

Collaborators and Investigators

Sponsor: Medtronic - MITG

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-21

Study Completion Date2025-07-22

Study Record Updates

Study Start Date2024-10-21

Study Completion Date2025-07-22

Terms related to this study

Additional Relevant MeSH Terms

Oxygen Saturation