A Normal Donor Sample Collection Study in Healthy Adults

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Astute Medical, Inc.

ClinicalTrials.gov Identifier:

NCT01318863

First received: March 17, 2011

Last updated: November 3, 2011

Last verified: September 2011

History of Changes

Purpose

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.

Condition
Healthy Normal Volunteers

Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	A Normal Donor Sample Collection Study in Healthy Adults

Further study details as provided by Astute Medical, Inc.:

Estimated Enrollment:	300
Study Start Date:	April 2011
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Healthy Adults

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01318863

Locations

United States, California
Apex Research Institute
Santa Ana, California, United States, 92705
United States, Nevada
Clinical Research Consortium
Las Vegas, Nevada, United States, 89119
United States, New York
Rochester Clinical Research, Inc.
Rochester, New York, United States, 14609
United States, Tennessee

Gray, Tennessee, United States, 37615

Memphis, Tennessee, United States, 38105
United States, Texas
Research Across America
Dallas, Texas, United States, 75234

Sponsors and Collaborators

Astute Medical, Inc.

More Information

No publications provided

Responsible Party:	Astute Medical, Inc.
ClinicalTrials.gov Identifier:	NCT01318863 History of Changes
Other Study ID Numbers:	AST-015
Study First Received:	March 17, 2011
Last Updated:	November 3, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Astute Medical, Inc.:

aged matched normal control samples

ClinicalTrials.gov processed this record on May 23, 2013

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