Safety and Performance Evaluation of the Rapid Ring Device

NCT ID: NCT01152983

Last Updated: 2010-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2010-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Healthy

Keywords

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Finger sticks Rapid Ring Finger sticks method of obtaining blood for diagnostic testing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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RapiDx Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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RapiDx Ltd

Principal Investigators

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Ella Naparstek, Prof.

Role: PRINCIPAL_INVESTIGATOR

Chairman of the Hematology Institute and the Department of Hematology and Bone Marrow Transplantation at Tel Aviv Sourasky Medical Center.

Locations

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Tel-Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status

Countries

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Israel

Central Contacts

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Boris Tartakovsky, PhD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Boris Tartakovsky, PhD

Role: primary

Other Identifiers

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CTIL - CL-001

Identifier Type: -

Identifier Source: org_study_id