Safety and Performance Evaluation of the Rapid Ring Device
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01152983|
Recruitment Status : Unknown
Verified June 2010 by RapiDx Ltd..
Recruitment status was: Not yet recruiting
First Posted : June 29, 2010
Last Update Posted : June 29, 2010
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Device: Rapid Ring||Phase 1 Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||August 2010|
|Estimated Primary Completion Date :||November 2010|
|Estimated Study Completion Date :||November 2010|
Device: Rapid Ring
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01152983
|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.|