Safety and Performance Evaluation of the Rapid Ring Device

June 28, 2010 updated by: RapiDx Ltd.

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)

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

Study Overview

Status

Unknown

Conditions

Healthy

Intervention / Treatment

Device: 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.

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 2
Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Israel
- - Tel Aviv, Israel
    - Tel-Aviv Sourasky Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Collection of at least 2 drops (approximately 50microliter) of blood within one minute. Time Frame: approximately 6 months	approximately 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Reduction in pain Time Frame: approximately 6 months	approximately 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Anticipated)

November 1, 2010

Study Completion (Anticipated)