HealthyNCT05717036
Refractix DSP and TS Meter-DSP Measurement Comparison
An observational study of Healthy, run by Reichert, Inc. at 1 site in United States.
Trial summary
The goal of this clinical trial is to compare the serum plasma measurement results between the FDA cleared TS Meter-DSP and investigational Refractix DSP. Study participants will be individuals being screened for plasma donation in a plasmaphereris center. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Serum Total Protein Measurement with TS Meter-DSP and Refractix DSP
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2023to 15 Feb 2023
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will be individuals presenting at a plasma collection center for plasma donation.
Who may be able to join
- Subjects must be between the ages of 18 and 90 years old
- Subjects must be able and willing to provide signed informed consent
- Subjects must be able to follow study instructions
Who cannot join
- Insufficient amount of plasma sample for use on either device in the study.
- Plasma samples of with total protein measurements outside of the 6.0 g/100ml to 9.0 g/100ml range will be excluded from the data analysis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hemarus Plasma
Lauderhill, Florida, 33313
Linton W Davis, 754-336-1503, ldavis@hemarus-plasma.com
Melvyn W Kramer, MD, 9783331997, melvynkramer@aol.com
About this study
The goal of this clinical trial is to compare the serum plasma measurement results between the FDA cleared TS Meter-DSP and investigational Refractix DSP. Study participants will be individuals being screened for plasma donation in a plasmaphereris center. The main question the study aims to answer is whether the measurement taken on the investigational Refractix DSP device is equivalent, defined as within +/- 0.3g/100ml, of the measurement taken on the TS Meter-DSP. Participants will be asked to provide a second capillary tube of blood (<0.085ml) from the fingerstick that is part of their routine pre-screening for plasma donation.
Read the detailed description
The TS Meter-DSP and investigational Refractix DSP are digital refractometers intended for the quantitative measurement of total protein in human serum or plasma. The devices are intended for use in plasma collection centers and are not for diagnostic purposes. Serum/plasma samples are taken from a successful microhematocrit assay and dispensed via pipette on to the instruments. The instruments measure the temperature compensated refractive index of the serum or plasma sample and digitally convert refractive index to an accurate total protein value. Potential donors with a total protein level of between 6.0 g/100ml and 9.0 g/100ml and that meet other pre-screening requirements are permitted to donate plasma.
These devices are FDA Class I in vitro diagnostic devices; FDA Regulation Number 862.2800 Refractometer for clinical use; with Product Code PSM, Refractometer for Donor Testing.
Participants will be those presenting for plasma donation. Ordinary pre-screening for plasma donation includes a fingerstick and the collection of one small capillary tube (<0.085ml) of blood. Participants who have consented to this study will be asked to supply a second capillary tube (<0.085ml) of blood for the clinical trial. The two samples will be centrifuged and hematocrit measured per the plasma center's standard operating procedures. One sample will be dispensed onto the TS Meter-DSP for total protein measurement. This measurement will be used to determine the individual's eligibility to donate plasma. The second sample will be dispensed on to the investigational Refractix DSP for total protein measurement. The measurements from both devices will be recorded on the Case Report Form. The study requires (36) participants with total protein measurements between 6.0 g/100ml and 9.0 g/100ml.
The primary analysis of data will include:
- a Grubb's test for outlying paired difference values will be performed. If outliers are detected and a plausible non-device failure mechanism can be identified (eg, operator or data entry error), the values will be excluded from the acceptance criterion calculations;
- an alpha=0.05 level equivalence test with an equivalence interval of +/- 0.3 g/100ml will be performed using the TOST (Two One Sample Test) procedure. A paired t-test 90% confidence interval for the difference in paired sample measurements will be constructed and reported; and
- calculate the percentage of measurement pairs falling outside of the +/-0.3 tolerance.
- Conditions
- Healthy
- Being tested
- Serum Total Protein Measurement with TS Meter-DSP and Refractix DSP
- Keywords
- serum total protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum Total Protein Measurement with TS Meter-DSP and Refractix DSPDevice
The two blood samples will be centrifuged and hematocrit measured per the plasma center's standard operating procedures. One participant sample will be dispensed onto the cleared TS Meter-DSP for a serum total protein measurement. This measurement will be used, along with other pre-screening information, to determine if the participant can donate plasma. The second participant sample will be dispensed onto the investigational Refractix DSP for a serum total protein measurement. It will be compared to the sample measurement taken on the cleared TS Meter-DSP.
| Study group | Role | What they receive |
|---|---|---|
| TS Meter-DSP Measurement and Refractix DSP Measurement | The study will involve blood serum samples from (36) participants. Participants will be those presenting at a plasma collection center for routine plasma donation. Ordinary pre-screening for plasma donation includes a fingerstick and the collection of one small capillary tube (<0.085ml) of blood. Participants will be asked to provide a second capillary tube (<0.085ml) of blood from this fingerstick. Receives: Device: Serum Total Protein Measurement with TS Meter-DSP and Refractix DSP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Total Protein Measurement Comparison
The purpose of this study is to show the investigational Refractix DSP refractometer yields equivalent measurement results to the predicate device TS Meter-DSP through comparison testing using human plasma samples.
Measured: Samples will be collected over one or two days at the plasma center. Data analysis by sponsor will be completed within 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start13 Feb 2023 (estimated)
- Primary completion15 Feb 2023 (estimated)
- Study completion15 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reichert, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717036
- Sponsor's protocol ID
- 13910000-TPR-30
- Status last verified
- Jan 2023
- First submitted
- 11 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refractix DSP and TS Meter-DSP Measurement Comparison
- ClinicalTrials.gov ID
- NCT05717036
- Acronym / sponsor ID
- 13910000-TPR-30
- Conditions
- Healthy
- Keywords
- serum total protein
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Reichert, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Feb 2023 (estimated)
- Primary completion
- 15 Feb 2023 (estimated)
- Study completion
- 15 Feb 2023 (estimated)
- First posted
- 8 Feb 2023 (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 goal of this clinical trial is to compare the serum plasma measurement results between the FDA cleared TS Meter-DSP and investigational Refractix DSP. Study participants will be individuals being screened for plasma donation in a plasmaphereris center. The main question the study aims to answer is whether the measurement taken on the investigational Refractix DSP device is equivalent, defined as within +/- 0.3g/100ml, of the measurement taken on the TS Meter-DSP. Participants will be asked to provide a second capillary tube of blood (<0.085ml) from the fingerstick that is part of their routine pre-screening for plasma donation.
Detailed description
The TS Meter-DSP and investigational Refractix DSP are digital refractometers intended for the quantitative measurement of total protein in human serum or plasma. The devices are intended for use in plasma collection centers and are not for diagnostic purposes. Serum/plasma samples are taken from a successful microhematocrit assay and dispensed via pipette on to the instruments. The instruments measure the temperature compensated refractive index of the serum or plasma sample and digitally convert refractive index to an accurate total protein value. Potential donors with a total protein level of between 6.0 g/100ml and 9.0 g/100ml and that meet other pre-screening requirements are permitted to donate plasma.
These devices are FDA Class I in vitro diagnostic devices; FDA Regulation Number 862.2800 Refractometer for clinical use; with Product Code PSM, Refractometer for Donor Testing.
Participants will be those presenting for plasma donation. Ordinary pre-screening for plasma donation includes a fingerstick and the collection of one small capillary tube (<0.085ml) of blood. Participants who have consented to this study will be asked to supply a second capillary tube (<0.085ml) of blood for the clinical trial. The two samples will be centrifuged and hematocrit measured per the plasma center's standard operating procedures. One sample will be dispensed onto the TS Meter-DSP for total protein measurement. This measurement will be used to determine the individual's eligibility to donate plasma. The second sample will be dispensed on to the investigational Refractix DSP for total protein measurement. The measurements from both devices will be recorded on the Case Report Form. The study requires (36) participants with total protein measurements between 6.0 g/100ml and 9.0 g/100ml.
The primary analysis of data will include:
- a Grubb's test for outlying paired difference values will be performed. If outliers are detected and a plausible non-device failure mechanism can be identified (eg, operator or data entry error), the values will be excluded from the acceptance criterion calculations;
- an alpha=0.05 level equivalence test with an equivalence interval of +/- 0.3 g/100ml will be performed using the TOST (Two One Sample Test) procedure. A paired t-test 90% confidence interval for the difference in paired sample measurements will be constructed and reported; and
- calculate the percentage of measurement pairs falling outside of the +/-0.3 tolerance.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TS Meter-DSP Measurement and Refractix DSP Measurement | – | Device: Serum Total Protein Measurement with TS Meter-DSP and Refractix DSPThe study will involve blood serum samples from (36) participants. Participants will be those presenting at a plasma collection center for routine plasma donation. Ordinary pre-screening for plasma donation includes a fingerstick and the collection of one small capillary tube (<0.085ml) of blood. Participants will be asked to provide a second capillary tube (<0.085ml) of blood from this fingerstick. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be individuals presenting at a plasma collection center for plasma donation.
Key inclusion criteria (3 listed)
- Subjects must be between the ages of 18 and 90 years old
- Subjects must be able and willing to provide signed informed consent
- Subjects must be able to follow study instructions
Key exclusion criteria (2 listed)
- Insufficient amount of plasma sample for use on either device in the study.
- Plasma samples of with total protein measurements outside of the 6.0 g/100ml to 9.0 g/100ml range will be excluded from the data analysis.
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 |
|---|---|---|
| Serum Total Protein Measurement with TS Meter-DSP and Refractix DSPThe two blood samples will be centrifuged and hematocrit measured per the plasma center's standard operating procedures. One participant sample will be dispensed onto the cleared TS Meter-DSP for a serum total protein measurement. This measurement will be used, along with other pre-screening information, to determine if the participant can donate plasma. The second participant sample will be dispensed onto the investigational Refractix DSP for a serum total protein measurement. It will be compared to the sample measurement taken on the cleared TS Meter-DSP. | Device | TS Meter-DSP Measurement and Refractix DSP Measurement |
Primary outcome
Serum Total Protein Measurement Comparison
Time frame: Samples will be collected over one or two days at the plasma center. Data analysis by sponsor will be completed within 8 weeks.
The purpose of this study is to show the investigational Refractix DSP refractometer yields equivalent measurement results to the predicate device TS Meter-DSP through comparison testing using human plasma samples.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
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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.
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 Healthy, run by Reichert, 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 3 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: status not confirmed, as of the sponsor's last update on 8 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Linton Davis (754-336-1503, ldavis@hemarus-plasma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Total Protein Measurement Comparison (time frame: Samples will be collected over one or two days at the plasma center. Data analysis by sponsor will be completed within 8 weeks.). 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 8 Feb 2023; AzTrials last refreshed its copy on 5 Nov 2026.