Safety and Performance Evaluation of the Rapid Ring Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01152983
Recruitment Status : Unknown
Verified June 2010 by RapiDx Ltd..
Recruitment status was:  Not yet recruiting
First Posted : June 29, 2010
Last Update Posted : June 29, 2010
Information provided by:
RapiDx Ltd.

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

Condition or disease Intervention/treatment Phase
Healthy Device: Rapid Ring Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : August 2010
Estimated Primary Completion Date : November 2010
Estimated Study Completion Date : November 2010

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.

Primary Outcome Measures :
  1. Collection of at least 2 drops (approximately 50microliter) of blood within one minute. [ Time Frame: approximately 6 months ]

Secondary Outcome Measures :
  1. Reduction in pain [ Time Frame: approximately 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01152983

Contact: Boris Tartakovsky, PhD

Tel-Aviv Sourasky Medical Center Not yet recruiting
Tel Aviv, Israel
Contact: Boris Tartakovsky, PhD   
Principal Investigator: Ella Naparstek, Prof.         
Sub-Investigator: Boris Tartakovsky, PhD         
Sponsors and Collaborators
RapiDx Ltd.
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.

Responsible Party: Erez Rozenfeld, RapiDx Ltd Identifier: NCT01152983     History of Changes
Other Study ID Numbers: CTIL - CL-001
First Posted: June 29, 2010    Key Record Dates
Last Update Posted: June 29, 2010
Last Verified: June 2010

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