A Comparative Study of the SoftTouch Non-Invasive Finger-Mounted Device

NCT00712361 | Completed DMC

• 4 other identifiers: CM-CL-R-007CMC 07015922 CMC 07015409HT 4502HTA 4502
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 4

Brief Summary

1. 1.Aim:
2. 2.Hypothesis:

Conditions

Accuracy of the SofTouch Device Measuring Blood Glucose and Other Parameters

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

Outcome Measures

Primary Outcomes (1)

• Non Invasive Screening of: Glucose, Hemoglobin, Hematocrit, Blood Pressure, Pulse, SpO2, CO2, pH.

  up to 2 minutes

Study Arms (1)

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.

Device: Non Invasive peripheral blood screening (Cnoga Medical Ltd.,SofTouch,OnlyTouch, CM-CL-R-007, CMC 07015922,HT 4502, HTA 4502)

Interventions

Non Invasive peripheral blood screening (Cnoga Medical Ltd.,SofTouch,OnlyTouch, CM-CL-R-007, CMC 07015922,HT 4502, HTA 4502) DEVICE

Non Invasive screening of various independent peripheral blood parameters: Glucose, hemoglobin, Hematocrit, blood pressure, pulse, SpO2, CO2, pH.

Also known as: Cnoga Medical Ltd., SoftTouch, SofTouch, Soft-Touch, OnlyTouch, CM-CL-R-007, CMC 07015922, HT 4502, HTA 4502

Group A

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cnoga Medical Ltd.: lead
• Carmel Medical Center: collaborator

Study Sites (4)

Patient's residence

Patient's Residence City, Patinet's Residence Province, Israel

Location

Carmel Medical Center

Haifa, Israel

Location

Lin Medical Center

Haifa, Israel

Location

CNOGA Medical Ltd.

Or Akiva, 30600, Israel

Location

Related Publications (1)

• 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

  BACKGROUND

Study Officials

• Eli Zuckerman, Prof.

  Carmel Medical Center - Head of Liver Unit

  PRINCIPAL INVESTIGATOR

• Yosef Segman, PhD

  Cnoga Medical Ltd.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2008
• First Posted: July 10, 2008
• Study Start: July 1, 2008
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: January 28, 2020

Record last verified: 2009-12

Locations

IL (4)