- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01152983
Safety and Performance Evaluation of the Rapid Ring Device
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 Overview
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 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
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Boris Tartakovsky, PhD
- Email: boris.tartakovsky@gmail.com
Study Locations
-
-
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Tel Aviv, Israel
- Tel-Aviv Sourasky Medical Center
-
Contact:
- Boris Tartakovsky, PhD
- Email: boris.tartakovsky@gmail.com
-
Principal Investigator:
- Ella Naparstek, Prof.
-
Sub-Investigator:
- Boris Tartakovsky, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Collection of at least 2 drops (approximately 50microliter) of blood within one minute.
Time Frame: approximately 6 months
|
approximately 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction in pain
Time Frame: approximately 6 months
|
approximately 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CTIL - CL-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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