Status:
UNKNOWN
Safety and Performance Evaluation of the Rapid Ring Device
Lead Sponsor:
RapiDx Ltd.
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to demonstrate the safety, performance and initial efficacy of the RapiDx device.
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 compa...
Eligibility Criteria
Inclusion
- Subject is healthy
- Subject's age is between 18 to 70 years old
- Subject must be capable of providing informed consent
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01152983
Start Date
August 1 2010
End Date
November 1 2010
Last Update
June 29 2010
Active Locations (1)
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1
Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel