Safety and Performance Evaluation of the Rapid Ring Device
NCT ID: NCT01152983
Last Updated: 2010-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2010-08-31
2010-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Rapid Ring
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.
Eligibility Criteria
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Inclusion Criteria
* Subject's age is between 18 to 70 years old
* Subject must be capable of providing informed consent
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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RapiDx Ltd.
INDUSTRY
Responsible Party
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RapiDx Ltd
Principal Investigators
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Ella Naparstek, Prof.
Role: PRINCIPAL_INVESTIGATOR
Chairman of the Hematology Institute and the Department of Hematology and Bone Marrow Transplantation at Tel Aviv Sourasky Medical Center.
Locations
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Tel-Aviv Sourasky Medical Center
Tel Aviv, , Israel
Countries
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Central Contacts
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Facility Contacts
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Boris Tartakovsky, PhD
Role: primary
Other Identifiers
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CTIL - CL-001
Identifier Type: -
Identifier Source: org_study_id