The purpose of this study is to demonstrate the safety, performance and initial efficacy of the RapiDx device.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel
Collection of at least 2 drops (approximately 50microliter) of blood within one minute.
Time frame: approximately 6 months
Reduction in pain
Time frame: approximately 6 months
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