Accuracy of the SofTouch Device Measuring Blood Glucose and Other ParametersNCT00712361
A Comparative Study of the SoftTouch Non-Invasive Finger-Mounted Device
A study testing Non Invasive peripheral blood screening (Cnoga Medical Ltd.,SofTouch,OnlyTouch, CM-CL-R-007, CMC 07015922,HT 4502, HTA 4502) in people with Accuracy of the SofTouch Device Measuring Blood Glucose and Other Parameters, run by Cnoga Medical Ltd. at 4 sites in Israel.
Trial summary
1. Aim: SoftTouch is a non-invasive device intending for use in the temporarily quantitative measurement of peripheral blood biomarkers. The aim of the clinical trial is to study the accuracy of the SoftTouch device compared with registered (FDA-approved) invasive and non-invasive devices. 2. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Accuracy of the SofTouch Device Measuring Blood Glucose and Other Parameters
- What is being tested?
- Non Invasive peripheral blood screening (Cnoga Medical Ltd.,SofTouch,OnlyTouch, CM-CL-R-007, CMC 07015922,HT 4502, HTA 4502)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 4 sitesIsrael
- Study dates
- Jul 2008to Aug 2014
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Questions regarding INCLUSION must all be answered YES for subject study entry
- Subject is 18 to 85 years of age? [ ]Yes
- Finger skin surface to be tested is free of injury or skin disease? [ ]Yes
- Subject is ambulatory? [ ]Yes
- Subject is willing and able to comply with the study requirements? [ ]Yes
- Subject is willing and able to provide written informed consent to participate in the study? [ ]Yes
Who cannot join
- Questions regarding EXCLUSION must all be answered NO for subject study entry
- Subject is currently hospitalized ambulatory free? [ ] No
- Subject is currently abusing alcohol or illicit drugs, or has a history of alcohol abuse or illicit substance abuse within the preceding 2 years. For the purposes of the present study, alcohol abuse is arbitrarily defined as frequent consumption of alcoholic beverages with an average daily intake of more than 40gr of ethanol. Subject is currently on methadone maintenance treatment programs are NOT eligible for this study? [ ] No
- Subject has a medical condition that requires frequent or prolonged use of systemic corticosteroids (eg. Severe asthma, severe arthritis or autoimmune conditions; organ transplantation, adrenal insufficiency)?[ ] No
- The skin area to be tested clean of any damage (e.g. spotless, uncontaminated, dirt free, and hygienic)? [ ] No
- Subject has any other concurrent medical or social condition likely to preclude compliance with the schedule of evaluations in the protocol, or likely to confound the efficacy or safety observations of the study (e.g. concurrent active malignancy; frequent or uncontrolled seizure disorder; severe psychiatric disorder requiring psychotropic medication; active tuberculosis, pneumonia or other severe infection under current treatment; lives in a country other than the investigative site; or has other medical or social circumstances likely to interfere with the schedule or evaluations? [ ] No
- A history of treated malignancy that is not in complete remission of chemotherapy and/or radiotherapy and with additional surgical intervention during the preceding 3 years? [ ] No
- Subject is enrolled or plans to enroll from this study for any personal reason ? [ ] No
Trial locations and contacts
4 sites in 1 country.
Israel4 sites
Carmel Medical Center
Haifa
Lin Medical Center
Haifa
CNOGA Medical Ltd.
Or Akiva, 30600
Patient's residence
Patient's Residence City, Patinet's Residence Province
About this study
Official title: A Comparative Clinical Trial to Assess the Accuracy of the SoftTouch. A Novel Non-invasive Device for Measuring Peripheral Blood Glucose, Carbon Dioxide, pH, Hemoglobin, Hematocrit, SpO2, Peripheral Pulse and Blood Pressure.
- Aim: SoftTouch is a non-invasive device intending for use in the temporarily quantitative measurement of peripheral blood biomarkers. The aim of the clinical trial is to study the accuracy of the SoftTouch 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 SoftTouch 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
Description of the Method:
- The method of measuring non-invasive peripheral physiological parameters such as Pulse, Blood Pressure, Blood pH, SpO2, CO2, Hemoglobin, Blood Glucose, Hematocrit and additional physiological parameters is based on the color distribution of a human tissue. SoftTouch is a finger-mounted device incorporated a dedicated light source and a color image sensor similar to a digital camera. The light transverses and is reflected from the tissue under consideration. Analyzing the tissue color distribution of the sampled real-time video in the frequency color space time domain may provide certain information about the biomarkers and vital-signs under consideration. The current study's goal is to find out if the results accuracy are satisfactory compared with regulatory cleared devices by the FDA and other notified bodies.
- The Patient signals shall be recorded as is for algorithm improvement, future research of additional bio parameters and calibration.
- the device is declared calibrated if executed successfully on the entire recorded data.
- for non invasive blood glucose the device shall be provided to selected diabetic patients for the own use at home.
- Being tested
- Non Invasive peripheral blood screening (Cnoga Medical Ltd.,SofTouch,OnlyTouch, CM-CL-R-007, CMC 07015922,HT 4502, HTA 4502)
- Keywords
- Invasive, Non-Invasive, Peripheral blood parameters, Finger mounted device, Blood tissue, Tissue color distribution, Accuracy, Tissue pigmentation, pH, Hemoglobin, Hematocrit, SpO2, Blood pressure, Pulse, CO2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non Invasive peripheral blood screening (Cnoga Medical Ltd.,SofTouch,OnlyTouch, CM-CL-R-007, CMC 07015922,HT 4502, HTA 4502)Device
Also called Cnoga Medical Ltd., SoftTouch, SofTouch, Soft-Touch
Non Invasive screening of various independent peripheral blood parameters: Glucose, hemoglobin, Hematocrit, blood pressure, pulse, SpO2, CO2, pH.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | The group A incorporates three subgroups of individuals at various ages. A.1 Age: 16 - 30 A.2 Age: 31 - 60 A.3 Age > 60 All subgroups will be randomly distributed according to the following factors: BMI, gender, race and hematocrit. Receives: Device: Non Invasive peripheral blood screening (Cnoga Medical Ltd.,SofTouch,OnlyTouch, CM-CL-R-007, CMC 07015922,HT 4502, HTA 4502) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non Invasive Screening of: Glucose, Hemoglobin, Hematocrit, Blood Pressure, Pulse, SpO2, CO2, pH.
Measured: up to 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Accuracy of the SofTouch Device Measuring Blood Glucose and Other ParametersStudies 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cnoga Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Carmel Medical Center
- Responsible party
- Sponsor
- Investigators
- Eli Zuckerman, Prof., Principal investigator, Carmel Medical Center - Head of Liver UnitYosef Segman, PhD, Study chair, Cnoga Medical Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00712361
- Sponsor's protocol ID
- CM-CL-R-007
- Other IDs
- CMC 07015922 CMC 07015409, HT 4502, HTA 4502
- Status last verified
- Dec 2009
- First submitted
- 7 Jul 2008
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
References: 1. Indian J Med Res. 2007 Mar;125(3):275-96 2. Self-monitoring of blood glucose in diabetes. Drug Ther Bull. 2007 ;45(9):65-9. Blood glucose monitoring: reducing the cost, increasing the benefit. 4. Hussain F, Evans ND, Sachedina N, Pickup JC, In vivo glucose monitoring: the clinical reality and the promise. Biosens Bioelectron. 2005 Apr 15;20(10):1897-902. 5. Sims AJ, Menes JA, Bousfield DR, Reay CA, Murray A. Automated non-invasive blood pressure devices: are they suitable for use? Blood Press Monit. 2005 Oct;10(5):275-81. 6. Funahashi J, Ohkubo T, Fukunaga H, Kikuya M, Takada N, Asayama K, Metoki H, Obara T, Inoue R, Hashimoto J, Totsune K, Kobayashi M, Imai Y. The economic impact of the introduction of home blood pressure measurement for the diagnosis and treatment of hypertension. Blood Press Monit. 2005 Dec;10(6):307-10. 7. Bobrie G, Chatellier G, Genes N, Clerson P, Vaur L, Vaisse B, Menard J, Mallion JM. Cardiovascular prognosis of
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. 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 SoftTouch. A Novel Non-invasive Device for Measuring Peripheral Blood Glucose, Carbon Dioxide, pH, Hemoglobin, Hematocrit, SpO2, Peripheral Pulse and Blood Pressure.
- ClinicalTrials.gov ID
- NCT00712361
- Acronym / sponsor ID
- CM-CL-R-007
- Keywords
- Invasive, Non-Invasive, Peripheral blood parameters, Finger mounted device, Blood tissue, Tissue color distribution, Accuracy, Tissue pigmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Cnoga Medical Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Carmel Medical Center
- Study start
- Jul 2008
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 10 Jul 2008 (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.
- Aim: SoftTouch is a non-invasive device intending for use in the temporarily quantitative measurement of peripheral blood biomarkers. The aim of the clinical trial is to study the accuracy of the SoftTouch 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 SoftTouch 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
Description of the Method:
- The method of measuring non-invasive peripheral physiological parameters such as Pulse, Blood Pressure, Blood pH, SpO2, CO2, Hemoglobin, Blood Glucose, Hematocrit and additional physiological parameters is based on the color distribution of a human tissue. SoftTouch is a finger-mounted device incorporated a dedicated light source and a color image sensor similar to a digital camera. The light transverses and is reflected from the tissue under consideration. Analyzing the tissue color distribution of the sampled real-time video in the frequency color space time domain may provide certain information about the biomarkers and vital-signs under consideration. The current study's goal is to find out if the results accuracy are satisfactory compared with regulatory cleared devices by the FDA and other notified bodies.
- The Patient signals shall be recorded as is for algorithm improvement, future research of additional bio parameters and calibration.
- the device is declared calibrated if executed successfully on the entire recorded data.
- for non invasive blood glucose the device shall be provided to selected diabetic patients for the own use at home.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Non Invasive peripheral blood screening (Cnoga Medical Ltd.,SofTouch,OnlyTouch, CM-CL-R-007, CMC 07015922,HT 4502, HTA 4502)The group A incorporates three subgroups of individuals at various ages. A.1 Age: 16 - 30 A.2 Age: 31 - 60 A.3 Age > 60 All subgroups will be randomly distributed according to the following factors: BMI, gender, race and hematocrit. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Questions regarding INCLUSION must all be answered YES for subject study entry
- Subject is 18 to 85 years of age? [ ]Yes
- Finger skin surface to be tested is free of injury or skin disease? [ ]Yes
- Subject is ambulatory? [ ]Yes
- Subject is willing and able to comply with the study requirements? [ ]Yes
Key exclusion criteria (8 listed)
- Questions regarding EXCLUSION must all be answered NO for subject study entry
- Subject is currently hospitalized ambulatory free? [ ] No
- Subject is currently abusing alcohol or illicit drugs, or has a history of alcohol abuse or illicit substance abuse within the preceding 2 years. For the purposes of the present study, alcohol abuse is arbitrarily defined as frequent consumption of alcoholic beverages with an average daily intake of more than 40gr of ethanol. Subject is currently on methadone maintenance treatment programs are NOT eligible for this study? [ ] No
- Subject has a medical condition that requires frequent or prolonged use of systemic corticosteroids (eg. Severe asthma, severe arthritis or autoimmune conditions; organ transplantation, adrenal insufficiency)?[ ] No
- The skin area to be tested clean of any damage (e.g. spotless, uncontaminated, dirt free, and hygienic)? [ ] No
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 screening (Cnoga Medical Ltd.,SofTouch,OnlyTouch, CM-CL-R-007, CMC 07015922,HT 4502, HTA 4502)Also: Cnoga Medical Ltd., SoftTouch, SofTouch, Soft-TouchNon Invasive screening of various independent peripheral blood parameters: Glucose, hemoglobin, Hematocrit, blood pressure, pulse, SpO2, CO2, pH. | Device | Group A |
Primary outcome
Non Invasive Screening of: Glucose, Hemoglobin, Hematocrit, Blood Pressure, Pulse, SpO2, CO2, pH.
Time frame: up to 2 minutes
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 28 Jan 2020.
- BackgroundReferences: 1. Indian J Med Res. 2007 Mar;125(3):275-96 2. Self-monitoring of blood glucose in diabetes. Drug Ther Bull. 2007 ;45(9):65-9. Blood glucose monitoring: reducing the cost, increasing the benefit. 4. Hussain F, Evans ND, Sachedina N, Pickup JC, In vivo glucose monitoring: the clinical reality and the promise. Biosens Bioelectron. 2005 Apr 15;20(10):1897-902. 5. Sims AJ, Menes JA, Bousfield DR, Reay CA, Murray A. Automated non-invasive blood pressure devices: are they suitable for use? Blood Press Monit. 2005 Oct;10(5):275-81. 6. Funahashi J, Ohkubo T, Fukunaga H, Kikuya M, Takada N, Asayama K, Metoki H, Obara T, Inoue R, Hashimoto J, Totsune K, Kobayashi M, Imai Y. The economic impact of the introduction of home blood pressure measurement for the diagnosis and treatment of hypertension. Blood Press Monit. 2005 Dec;10(6):307-10. 7. Bobrie G, Chatellier G, Genes N, Clerson P, Vaur L, Vaisse B, Menard J, Mallion JM. Cardiovascular prognosis of
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.
Eli Zuckerman, Prof. principal investigator
Carmel Medical Center - Head of Liver Unit
Yosef Segman, PhD study chair
Cnoga Medical Ltd.
4 sites 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 screening (Cnoga Medical Ltd.,SofTouch,OnlyTouch, CM-CL-R-007, CMC 07015922,HT 4502, HTA 4502) in people with Accuracy of the SofTouch Device Measuring Blood Glucose and Other Parameters, run by Cnoga Medical Ltd. at 4 sites in Israel.
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 6 inclusion and 8 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 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Israel. 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?
Non Invasive Screening of: Glucose, Hemoglobin, Hematocrit, Blood Pressure, Pulse, SpO2, CO2, pH. (time frame: up to 2 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00712361, which also lists 1 linked publication.
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 28 Jan 2020.