Safety and Performance Evaluation of the Rapid Ring Device
Recruitment status was Not yet recruiting
The purpose of this study is to demonstrate the safety, performance and initial efficacy of the RapiDx device.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)|
- Collection of at least 2 drops (approximately 50microliter) of blood within one minute. [ Time Frame: approximately 6 months ] [ Designated as safety issue: No ]
- Reduction in pain [ Time Frame: approximately 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||November 2010|
|Estimated Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Device: Rapid Ring
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.
|Contact: Boris Tartakovsky, PhDfirstname.lastname@example.org|
|Tel-Aviv Sourasky Medical Center||Not yet recruiting|
|Tel Aviv, Israel|
|Contact: Boris Tartakovsky, PhD email@example.com|
|Principal Investigator: Ella Naparstek, Prof.|
|Sub-Investigator: Boris Tartakovsky, PhD|
|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.|