A Comparative Clinical Trial of the TensorTip, a Novel Non Invasive Device for Measurement Blood Parameters

NCT01196533 | Completed Results

• 1 other identifier: CMIL-MHUS-V1.0
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anemia; Diabetes; Heart Disease; High Blood Pressure; Hypotension; Metabolic Diseases; Respiratory Diseases

Outcome Measures

Primary Outcomes (1)

• 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.

  one year

Study Arms (1)

Non Invasive Monitoring

EXPERIMENTAL

Intervention: Device: Non invasive peripheral blood monitoring

Device: Non invasive peripheral blood monitoring

Interventions

Non invasive peripheral blood monitoring DEVICE

non invasive monitoring

Non Invasive Monitoring

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cnoga Medical Ltd.: lead

Study Sites (1)

Atlantic Health - Morristown Memorial Hospital- Cardiovascular Medicine

Morristown, New Jersey, 07962-1905, United States

Location

Related Links

• Sponsor website.

MeSH Terms

Conditions

Anemia; Diabetes Mellitus; Heart Diseases; Hypertension; Hypotension; Metabolic Diseases; Respiratory Tract Diseases

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Endocrine System Diseases; Cardiovascular Diseases; Vascular Diseases

Results Point of Contact

• Title: Dr. Frank Smart
• Organization: Morristowm Memorial Hospital

frank.smart@atlantichealth.org

973-214-2601

Study Officials

• Frank Smart, M.D

  Chairman of the Cardiovascular Medicine Department at Morritwon Memorial Hospital and Atlantic Health

  PRINCIPAL INVESTIGATOR

• Yosef Segman, PhD

  Cnoga Medical Ltd.

  STUDY CHAIR

• Donna Hesari, BSN

  Atlantic Health System, Department of Cardiovascular Medicine

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: August 29, 2010
• First Posted: September 8, 2010
• Study Start: August 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: August 1, 2014
• Last Updated: January 31, 2019
• Results First Posted: January 31, 2019

Record last verified: 2018-07

Locations

US (1)