Various ComorbiditiesNCT01638455
Pulse CO-Oximetry Noninvasive Monitoring and Laboratory Measurements of Subject Blood Samples
A study testing Noninvasive device in people with Various Comorbidities, run by Masimo Corporation at 1 site in United States.
Trial summary
Characterize Masimo noninvasive technology in spot check reading on subjects and make comparison to invasive blood sampling tested on reference analyzers. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Various Comorbidities
- What is being tested?
- Noninvasive device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,776 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to 7 Sep 2016
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Male or female of any age ≥ 3 kg.
- Subjects may include healthy volunteers, outpatient or inpatient populations
Who cannot join
- Subjects with skin abnormalities at the planned application sites that may interfere with sensor application or trans-illumination of the site, such as burns, scar tissue, nail polish, acrylic nails, infections, etc.
- Subjects deemed not suitable for study at the discretion of the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Noninvasive Parameter Testing With Pulse CO-Oximetry and Measurement of Blood Constituents With In-Vitro Analyzers
Characterize Masimo noninvasive technology in spot check reading on subjects and make comparison to invasive blood sampling tested on reference analyzers.
Read the detailed description
Noninvasive readings from subjects done according to manufacturer's directions of use compared to simultaneously derived blood samples measured on in vitro analyzers
- Conditions
- Various Comorbidities
- Being tested
- Noninvasive device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive deviceDevice
Noninvasive device
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | All subjects will be enrolled in the test group and will receive the noninvasive device Receives: Device: Noninvasive device |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startJun 2012
- Primary completion7 Sep 2016
- Study completion7 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Various ComorbiditiesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 2,776 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masimo Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01638455
- Sponsor's protocol ID
- Masimo-Noninvasive 1
- Status last verified
- May 2017
- First submitted
- 9 Jul 2012
- Last updated
- 15 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Parameter Testing With Pulse CO-Oximetry and Measurement of Blood Constituents With In-Vitro Analyzers
- ClinicalTrials.gov ID
- NCT01638455
- Acronym / sponsor ID
- Masimo-Noninvasive 1
- Conditions
- Various Comorbidities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,776 participants (actual)
- Lead sponsor
- Masimo CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2012 (actual)
- Primary completion
- 7 Sep 2016 (actual)
- Study completion
- 7 Sep 2016 (actual)
- First posted
- 11 Jul 2012 (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.
Characterize Masimo noninvasive technology in spot check reading on subjects and make comparison to invasive blood sampling tested on reference analyzers.
Detailed description
Noninvasive readings from subjects done according to manufacturer's directions of use compared to simultaneously derived blood samples measured on in vitro analyzers
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Device: Noninvasive deviceAll subjects will be enrolled in the test group and will receive the noninvasive device |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female of any age ≥ 3 kg.
- Subjects may include healthy volunteers, outpatient or inpatient populations
Key exclusion criteria (2 listed)
- Subjects with skin abnormalities at the planned application sites that may interfere with sensor application or trans-illumination of the site, such as burns, scar tissue, nail polish, acrylic nails, infections, etc.
- Subjects deemed not suitable for study at the discretion of the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Noninvasive deviceNoninvasive device | Device | Test Group |
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 15 May 2017.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noninvasive device in people with Various Comorbidities, run by Masimo Corporation 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 2 inclusion and 2 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 15 May 2017. 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.
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 15 May 2017.