AnemiaNCT01196533
A Comparative Clinical Trial of the TensorTip, a Novel Non Invasive Device for Measurement Blood Parameters
A study testing Non invasive peripheral blood monitoring in people with Anemia and Diabetes, run by Cnoga Medical Ltd. at 1 site in United States.
Trial summary
1. Aim: The aim of the clinical trial is to study the accuracy of the TensorTip device compared with registered (FDA-approved) invasive and non-invasive devices. 2. Hypothesis: Human physiological biomarkers may be measured from the color distribution of the internal or external (skin) tissue. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anemia, Diabetes, Heart Disease
- What is being tested?
- Non invasive peripheral blood monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Aug 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female, age > 18
- Patients with cardiovascular disease and/or with diabetes mellitus type I or II and/or with COPD.
- Patients receiving coronary artery bypass with or without valve repair.
- Able to sign an informed consent.
Who cannot join
- Refusal to sign an informed consent and to participate in the study.
- Participant plans to enroll in another other clinical trial of an investigational agent while participating in this study.
- Below the age of 18.
Trial locations and contacts
1 site in 1 country.
United States1 site
Atlantic Health - Morristown Memorial Hospital- Cardiovascular Medicine
Morristown, New Jersey, 07962-1905
About this study
Official title: A Comparative Clinical Trial to Assess the Accuracy of the TensorTip, a Novel Non Invasive Device for the Measurement of Physiological and Blood Chemistry Parameters
- Aim: The aim of the clinical trial is to study the accuracy of the TensorTip device compared with registered (FDA-approved) invasive and non-invasive devices.
- Hypothesis:
Human physiological biomarkers may be measured from the color distribution of the internal or external (skin) tissue. The technology of the TensorTip finger-mounted device is based on the color distribution of the peripheral blood tissue, which enables the measurement of certain biomarkers and vital signs under consideration.
Read the detailed description
The TensorTip (previously named Soft Touch) is a novel non invasive Finger tip device that. The Tensor Tip is a non-invasive device which was designed and aimed to measure a wide range of physiological and bio-parameters such as blood glucose, hemoglobin and hematocrit, blood PH, oxygen saturation SpO2, blood carbon dioxide, blood pressure, peripheral pulse and more based on the temporarily color distribution of the tissue under consideration. The Tensor Tip is based on real time color image sensor, real time photographing the fingertip tissue. A color image sensor of the type used in the Tensor Tip enables a wide range of information in the spectral, resolution, dynamic range and time domains enabling further investigation of the blood chromatic changes as a function body physiology. The concept behind this investigation reflects the idea that a change in human physiology condition would temporarily change the blood pigmentation.
The present study is aimed to assess the accuracy of the novel device in measuring all the above mentioned parameters by recording AS IS the change of the fingertip color tissue while simultaneous recording the standard invasive measured parameters on daily or periodic routine in the hospitalized patients.
This vast data recordings (tissue and references) enable the Tensor tip to analyze a particular bio parameter. The tensor tip is calibrated to a certain bio parameter based on the vast data set collected.
The bio parameter under consideration are: Arterial Systolic and Diastolic, MAP, PA systolic, PA Diastolic, CO, Heart rate, Stroke volume, WBC, RBC, Hgb, HCT ,Iron, PLT, PH, PCO2, PO2, HCO3, SaO2 , Na, K, Cl, CO2, Bun, Cr, Gluc, HGB (A1C),TBiLi, LDL, HDL.
This study hopes to demonstrate the connection between blood color pigmentation and certain bio parameters for simplifying monitoring procedure and particular home monitoring.
- Conditions
- Anemia, Diabetes, Heart Disease, High Blood Pressure, Hypotension, Metabolic Diseases
- Being tested
- Non invasive peripheral blood monitoring
- Medical subject headings
- Anemia, Diabetes Mellitus, Heart Diseases, Hypertension, Hypotension, Metabolic Diseases, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non invasive peripheral blood monitoringDevice
non invasive monitoring
| Study group | Role | What they receive |
|---|---|---|
| Non Invasive Monitoring | Experimental | Intervention: Device: Non invasive peripheral blood monitoring Receives: Device: Non invasive peripheral blood monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the TensorTip Accuracy Against Hospital Periodical Readings.
To validate the parameters with similar measures obtained with standard invasive techniques in hospitalized patients.
Methodology:
Eligible real time color signal obtained by the TensorTip shall be recorded simultaneously during the monitoring performed.
An algorithm shall be designed according to the blood color distribution to each parameter and a final test shall be recorded signals.
Statistical analysis for each parameter shall perform on the entire eligible recorded signals.
Determination of Accuracy:
Err = √(1/N ∑N (Ref(k)-NewDevice(k)) ^2 ) (k=1)
For each parameter a satisfactory result is considered when Err satisfies the industry requirement.
Results viewing Each parameter comparative study shall be presented on a (X,Y) plan versus a regression line where X - represents the results measured by TensorTip and Y - the reference results.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionJul 2013
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnemiaStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cnoga Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Smart, M.D, Principal investigator, Chairman of the Cardiovascular Medicine Department at Morritwon Memorial Hospital and Atlantic HealthYosef Segman, PhD, Study chair, Cnoga Medical Ltd.Donna Hesari, BSN, Study director, Atlantic Health System, Department of Cardiovascular Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01196533
- Sponsor's protocol ID
- CMIL-MHUS-V1.0
- Status last verified
- Jul 2018
- First submitted
- 29 Aug 2010
- Last updated
- 31 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Clinical Trial to Assess the Accuracy of the TensorTip, a Novel Non Invasive Device for the Measurement of Physiological and Blood Chemistry Parameters
- ClinicalTrials.gov ID
- NCT01196533
- Acronym / sponsor ID
- CMIL-MHUS-V1.0
- Conditions
- Anemia, Diabetes, Heart Disease, High Blood Pressure, Hypotension, Metabolic Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Cnoga Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 8 Sep 2010 (estimated)
- Results
- Posted 31 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Aim: The aim of the clinical trial is to study the accuracy of the TensorTip device compared with registered (FDA-approved) invasive and non-invasive devices.
- Hypothesis:
Human physiological biomarkers may be measured from the color distribution of the internal or external (skin) tissue. The technology of the TensorTip finger-mounted device is based on the color distribution of the peripheral blood tissue, which enables the measurement of certain biomarkers and vital signs under consideration.
Detailed description
The TensorTip (previously named Soft Touch) is a novel non invasive Finger tip device that. The Tensor Tip is a non-invasive device which was designed and aimed to measure a wide range of physiological and bio-parameters such as blood glucose, hemoglobin and hematocrit, blood PH, oxygen saturation SpO2, blood carbon dioxide, blood pressure, peripheral pulse and more based on the temporarily color distribution of the tissue under consideration. The Tensor Tip is based on real time color image sensor, real time photographing the fingertip tissue. A color image sensor of the type used in the Tensor Tip enables a wide range of information in the spectral, resolution, dynamic range and time domains enabling further investigation of the blood chromatic changes as a function body physiology. The concept behind this investigation reflects the idea that a change in human physiology condition would temporarily change the blood pigmentation.
The present study is aimed to assess the accuracy of the novel device in measuring all the above mentioned parameters by recording AS IS the change of the fingertip color tissue while simultaneous recording the standard invasive measured parameters on daily or periodic routine in the hospitalized patients.
This vast data recordings (tissue and references) enable the Tensor tip to analyze a particular bio parameter. The tensor tip is calibrated to a certain bio parameter based on the vast data set collected.
The bio parameter under consideration are: Arterial Systolic and Diastolic, MAP, PA systolic, PA Diastolic, CO, Heart rate, Stroke volume, WBC, RBC, Hgb, HCT ,Iron, PLT, PH, PCO2, PO2, HCO3, SaO2 , Na, K, Cl, CO2, Bun, Cr, Gluc, HGB (A1C),TBiLi, LDL, HDL.
This study hopes to demonstrate the connection between blood color pigmentation and certain bio parameters for simplifying monitoring procedure and particular home monitoring.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non Invasive Monitoring | Experimental | Device: Non invasive peripheral blood monitoringIntervention: Device: Non invasive peripheral blood monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, age > 18
- Patients with cardiovascular disease and/or with diabetes mellitus type I or II and/or with COPD.
- Patients receiving coronary artery bypass with or without valve repair.
- Able to sign an informed consent.
Key exclusion criteria (3 listed)
- Refusal to sign an informed consent and to participate in the study.
- Participant plans to enroll in another other clinical trial of an investigational agent while participating in this study.
- Below the age of 18.
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 peripheral blood monitoringnon invasive monitoring | Device | Non Invasive Monitoring |
Primary outcome
Comparison of the TensorTip Accuracy Against Hospital Periodical Readings.
Time frame: one year
To validate the parameters with similar measures obtained with standard invasive techniques in hospitalized patients. Methodology: Eligible real time color signal obtained by the TensorTip shall be recorded simultaneously during the monitoring performed. An algorithm shall be designed according to the blood color distribution to each parameter and a final test shall be recorded signals. Statistical analysis for each parameter shall perform on the entire eligible recorded signals. Determination of Accuracy: Err = √(1/N ∑N (Ref(k)-NewDevice(k)) ^2 ) (k=1) For each parameter a satisfactory result is considered when Err satisfies the industry requirement. Results viewing Each parameter comparative study shall be presented on a (X,Y) plan versus a regression line where X - represents the results measured by TensorTip and Y - the reference results.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Sponsor website.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Frank Smart, M.D principal investigator
Chairman of the Cardiovascular Medicine Department at Morritwon Memorial Hospital and Atlantic Health
Yosef Segman, PhD study chair
Cnoga Medical Ltd.
Donna Hesari, BSN study director
Atlantic Health System, Department of Cardiovascular Medicine
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 peripheral blood monitoring in people with Anemia and Diabetes, run by Cnoga Medical Ltd. 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 4 inclusion and 3 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 31 Jan 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?
Yes. Results are posted in the registry (first posted 31 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Comparison of the TensorTip Accuracy Against Hospital Periodical Readings. (time frame: one year). 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 31 Jan 2019.