Healthy Normal VolunteersNCT01318863
A Normal Donor Sample Collection Study in Healthy Adults
An observational study of Healthy Normal Volunteers, run by Astute Medical, Inc. at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Normal Volunteers
- How many people
- 300 participants
- Where
- 6 sitesUnited States
- Study dates
- Apr 2011to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Adults
Who may be able to join
- Apparently healthy adults (age ≥ 21 years)
- Provide written informed consent for study participation
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Research Across America
Dallas, Texas, 75234
Study site
Gray, Tennessee, 37615
Clinical Research Consortium
Las Vegas, Nevada, 89119
Study site
Memphis, Tennessee, 38105
Rochester Clinical Research, Inc.
Rochester, New York, 14609
Apex Research Institute
Santa Ana, California, 92705
About this study
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.
- Conditions
- Healthy Normal Volunteers
- Keywords
- aged matched normal control samples
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Normal VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Astute Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01318863
- Sponsor's protocol ID
- AST-015
- Status last verified
- Sep 2011
- First submitted
- 17 Mar 2011
- Last updated
- 7 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Normal Donor Sample Collection Study in Healthy Adults
- ClinicalTrials.gov ID
- NCT01318863
- Acronym / sponsor ID
- AST-015
- Conditions
- Healthy Normal Volunteers
- Keywords
- aged matched normal control samples
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Astute Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Sep 2011 (actual)
- First posted
- 21 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Adults
Key inclusion criteria (2 listed)
- Apparently healthy adults (age ≥ 21 years)
- Provide written informed consent for study participation
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Normal Volunteers, run by Astute Medical, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2011; AzTrials last refreshed its copy on 27 Oct 2026.