Near Infrared SpectroscopyNCT01326819
Comparison of Normal Readings and Repeatability Across Skin Colors
An observational study of Near Infrared Spectroscopy, run by Nonin Medical, Inc at 1 site in United States.
Trial summary
Observational comparison study of three commercially available regional oxygen saturation devices on a wide range of skin colors. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Near Infrared Spectroscopy
- How many people
- 231 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Dec 2012
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community sample
Who may be able to join
- Male or Female
- of any race or ethnicity
- greater than eighteen years of age
- weighs greater than or equal to 40 kilograms
- is not currently admitted to the hospital
- is not known to be pregnant
- understands English
- is willing and able to provide informed consent and comply with study procedures
Who cannot join
- is less than eighteen years of age
- weighs less than 40 kilograms
- if known to be pregnant
- is a current patient in the hospital
- does not understand English
- has known anemia
- is unwilling and able to provide informed consent and comply with study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Comparison Study of Three Regional Oxygen Saturation (rSO2) Systems Across a Wide Range of Skin Colors
Observational comparison study of three commercially available regional oxygen saturation devices on a wide range of skin colors.
- Conditions
- Near Infrared Spectroscopy
- Keywords
- Near infrared spectroscopy, Skin pigmentation, Regional oxygen saturation
- Medical subject headings
- Pigmentation Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean and standard deviation of readings with all four regional oxygen saturation devices.
Measured: Data analysis will be performed when 240 subjects have been enrolled (7 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Near Infrared SpectroscopyStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nonin Medical, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kumar Belani, MD, Principal investigator, Univeristy of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326819
- Sponsor's protocol ID
- QATP1962
- Status last verified
- Nov 2012
- First submitted
- 3 Mar 2011
- Last updated
- 13 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Study of Three Regional Oxygen Saturation (rSO2) Systems Across a Wide Range of Skin Colors
- ClinicalTrials.gov ID
- NCT01326819
- Acronym / sponsor ID
- QATP1962
- Conditions
- Near Infrared Spectroscopy
- Keywords
- Near infrared spectroscopy, Skin pigmentation, Regional oxygen saturation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Nonin Medical, IncIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 31 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.
Observational comparison study of three commercially available regional oxygen saturation devices on a wide range of skin colors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (8 listed)
- Male or Female
- of any race or ethnicity
- greater than eighteen years of age
- weighs greater than or equal to 40 kilograms
- is not currently admitted to the hospital
Key exclusion criteria (7 listed)
- is less than eighteen years of age
- weighs less than 40 kilograms
- if known to be pregnant
- is a current patient in the hospital
- does not understand English
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
The mean and standard deviation of readings with all four regional oxygen saturation devices.
Time frame: Data analysis will be performed when 240 subjects have been enrolled (7 months)
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 13 May 2013.
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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.
Kumar Belani, MD principal investigator
Univeristy of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Near Infrared Spectroscopy, run by Nonin Medical, Inc at 1 site 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 8 inclusion and 7 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 13 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does the primary outcome measure?
The mean and standard deviation of readings with all four regional oxygen saturation devices. (time frame: Data analysis will be performed when 240 subjects have been enrolled (7 months)). It is what the study was designed to measure, not a finding.
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 13 May 2013.