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Safety and Performance Evaluation of the Rapid Ring Device

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by RapiDx Ltd..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
RapiDx Ltd.
ClinicalTrials.gov Identifier:
NCT01152983
First received: June 27, 2010
Last updated: June 28, 2010
Last verified: June 2010
History of Changes
  Purpose

The purpose of this study is to demonstrate the safety, performance and initial efficacy of the RapiDx device.


Condition Intervention Phase
Healthy
 Device: Rapid Ring
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single Center, Open Label, Prospective, Non-comparative, Non-randomized Study to Assess the Safety and Performance of the Rapid Ring Device (Comparative Study to Assess the Pain Reduction)

Further study details as provided by RapiDx Ltd.:

Primary Outcome Measures:
  • Collection of at least 2 drops (approximately 50microliter) of blood within one minute. [ Time Frame: approximately 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction in pain [ Time Frame: approximately 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: August 2010
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Rapid Ring
    Rapid Ring is a ring-shaped device that encircles the distal phalanx of the middle finger and blocks the arterial blood to quickly and passively withdraw blood following a finger stick, and to reduce the pain of the lancet.
    Other Name: Rapid Ring
Detailed Description:

The study will be a single center, open label, prospective, non-comparative, randomized trial and assess the safety and performance of the Rapid Ring device. In order to assess pain reduction, a comparative study will be performed and each subject will serve as his/her own control.

Clinical assessment for all 100% patients will occur at baseline. All participants will be men and women above the age of 18. The trial will be conducted at a Medical Center.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is healthy
  • Subject's age is between 18 to 70 years old
  • Subject must be capable of providing informed consent

Exclusion Criteria:

  • Clotting disorders
  • Subject has a clinically significant untreated chronic disease which may unable him/ her to participate in the study.
  • Subject is taking anti-coagulant medication
  • Non-intact finger tip (left middle/ring finger)
  • Skin disease on the subject finger
  • Abnormal blood pressure
  • Pregnant or lactating women
  • Menstrual period
  • Previous diagnosis of HIV or Hepatitis
  • Participation in other clinical investigations within previous 30 days
  • Peripheral blood vessels diseases
  • Diabetes
  • Neuropathic pain
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01152983

Contacts
Contact: Boris Tartakovsky, PhD boris.tartakovsky@gmail.com

Locations
Israel
Tel-Aviv Sourasky Medical Center Not yet recruiting
Tel Aviv, Israel
Contact: Boris Tartakovsky, PhD         boris.tartakovsky@gmail.com    
Principal Investigator: Ella Naparstek, Prof.            
Sub-Investigator: Boris Tartakovsky, PhD            
Sponsors and Collaborators
RapiDx Ltd.
Investigators
Principal Investigator: Ella Naparstek, Prof. Chairman of the Hematology Institute and the Department of Hematology and Bone Marrow Transplantation at Tel Aviv Sourasky Medical Center.
  More Information

No publications provided

Responsible Party: Erez Rozenfeld, RapiDx Ltd
ClinicalTrials.gov Identifier: NCT01152983     History of Changes
Other Study ID Numbers: CTIL - CL-001
Study First Received: June 27, 2010
Last Updated: June 28, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by RapiDx Ltd.:
Finger sticks
Rapid Ring
Finger sticks method of obtaining blood for diagnostic testing

ClinicalTrials.gov processed this record on May 19, 2013