Reproducibility of ResultsNCT03991637
Non-Invasive Blood Test Cross-Validation Study
A study testing Non-Invasive Comprehensive Metabolic Panel in people with Reproducibility of Results and Safety Issues, run by Joseph Allen Jr. at 1 site in United States.
Trial summary
The study considers a cross-validation approach to determine the effectiveness of a non-invasive comprehensive metabolic panel (NICMP), relative to the venipuncture method. The NICMP machine learned powered device utilizes a light sensor to capture readings from either palm. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Reproducibility of Results, Safety Issues
- What is being tested?
- Non-Invasive Comprehensive Metabolic Panel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2018to 1 Mar 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Undiagnosed population
Who cannot join
- Diagnosed population, pregnant women, mental heath/disabled, prisoners, fetus or deceased
Trial locations and contacts
1 site in 1 country.
United States1 site
Altru Health System
Grand Forks, North Dakota, 58201
About this study
Official title: Remote Sensing Comprehensive Metabolic Panel
The study considers a cross-validation approach to determine the effectiveness of a non-invasive comprehensive metabolic panel (NICMP), relative to the venipuncture method. The NICMP machine learned powered device utilizes a light sensor to capture readings from either palm. The study (n=90) proves an agreement and strong correlation with respect to the NICMP and venipuncture blood draw.
- Conditions
- Reproducibility of Results, Safety Issues
- Being tested
- Non-Invasive Comprehensive Metabolic Panel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Invasive Comprehensive Metabolic PanelDevice
The device utilizes spectroscopy and machine learning to detect metabolic analyte concentrations.
| Study group | Role | What they receive |
|---|---|---|
| NICMP Spectral Reading | Experimental | Non-invasive spectral data is collected from this arm to function as the intervention of interest. Receives: Device: Non-Invasive Comprehensive Metabolic Panel |
| Venipuncture CMP | Active comparator | A standard CMP blood draw is performed to function as the "gold standard" reference value.
Specifically, the outcome of the experimental arm is cross-validated against the active comparator arm to determine the NICMP accuracy, relative to the venipuncture method. Receives: Device: Non-Invasive Comprehensive Metabolic Panel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of Non-Invasive Comprehensive Metabolic Panel
Determine the effectiveness, in terms of accuracy, of the NICMP against the venipuncture CMP (i.e. reference value).
Measured: 2-minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start18 Jul 2018
- Primary completion11 Sep 2018
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reproducibility of ResultsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joseph Allen Jr.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of North Dakota
- Responsible party
- Sponsor-investigator, Joseph Allen Jr., Concord Medical Technology Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03991637
- Sponsor's protocol ID
- IRB-201807-004
- Status last verified
- Jun 2019
- First submitted
- 1 Jun 2019
- Last updated
- 24 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Sensing Comprehensive Metabolic Panel
- ClinicalTrials.gov ID
- NCT03991637
- Acronym / sponsor ID
- IRB-201807-004
- Conditions
- Reproducibility of Results, Safety Issues
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Joseph Allen Jr.Industry (pharma, biotech, devices)
- Collaborators
- University of North Dakota
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 11 Sep 2018 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 19 Jun 2019 (actual)
- 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.
The study considers a cross-validation approach to determine the effectiveness of a non-invasive comprehensive metabolic panel (NICMP), relative to the venipuncture method. The NICMP machine learned powered device utilizes a light sensor to capture readings from either palm. The study (n=90) proves an agreement and strong correlation with respect to the NICMP and venipuncture blood draw.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NICMP Spectral Reading | Experimental | Device: Non-Invasive Comprehensive Metabolic PanelNon-invasive spectral data is collected from this arm to function as the intervention of interest. |
| Venipuncture CMP | Active comparator | Device: Non-Invasive Comprehensive Metabolic PanelA standard CMP blood draw is performed to function as the "gold standard" reference value. Specifically, the outcome of the experimental arm is cross-validated against the active comparator arm to determine the NICMP accuracy, relative to the venipuncture method. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undiagnosed population
Key exclusion criteria (1 listed)
- Diagnosed population, pregnant women, mental heath/disabled, prisoners, fetus or deceased
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 |
|---|---|---|
| Non-Invasive Comprehensive Metabolic PanelThe device utilizes spectroscopy and machine learning to detect metabolic analyte concentrations. | Device | NICMP Spectral Reading, Venipuncture CMP |
Primary outcome
Performance of Non-Invasive Comprehensive Metabolic Panel
Time frame: 2-minutes
Determine the effectiveness, in terms of accuracy, of the NICMP against the venipuncture CMP (i.e. reference value).
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 24 Jun 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Invasive Comprehensive Metabolic Panel in people with Reproducibility of Results and Safety Issues, run by Joseph Allen Jr. 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 1 inclusion and 1 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 24 Jun 2019. 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?
Performance of Non-Invasive Comprehensive Metabolic Panel (time frame: 2-minutes). 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 24 Jun 2019.