A Normal Donor Sample Collection Study in Healthy Adults

Astute Medical, Inc.4 sites in 1 country300 target enrollmentApril 2011

ConditionsHealthy Normal Volunteers

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Healthy Normal Volunteers
Sponsor: Astute Medical, Inc.
Enrollment: 300
Locations: 4
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

More than one site will participate in the collection of blood and urine samples from healthy adult subjects. These samples will be used for future testing to serve as aged-matched normal controls and to establish normal reference ranges in the development of new invitro diagnostic devices.

Registry

clinicaltrials.gov

Start Date

April 2011

End Date

September 2011

Last Updated

14 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Astute Medical, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Apparently healthy adults (age ≥ 21 years)
•Provide written informed consent for study participation

Exclusion Criteria

•Any known or suspected acute illness or condition - including acute infections - at the time of enrollment or within the previous 30 days;
•Any known or suspected significant chronic medical conditions (such as diabetes, coronary artery disease, renal insufficiency, hypertension, hypercholesterolemia, chronic inflammatory diseases \[e.g., rheumatoid arthritis\], cancer, etc);
•Trauma-related surgery within the last 6 months;
•Any surgery, hospitalization or institutionalization (such as in a nursing home) during the previous 3 months;
•Received any blood product transfusion within the previous 2 months;
•Pregnant women or children;
•Prisoners or institutionalized individuals;
•Already provided blood or urine samples for this study.