NCT01152983

Brief Summary

The purpose of this study is to demonstrate the safety, performance and initial efficacy of the RapiDx device.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 29, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

June 29, 2010

Status Verified

June 1, 2010

Enrollment Period

3 months

First QC Date

June 27, 2010

Last Update Submit

June 28, 2010

Conditions

Healthy

Keywords

Finger sticksRapid RingFinger sticks method of obtaining blood for diagnostic testing

Outcome Measures

Primary Outcomes (1)

  • Collection of at least 2 drops (approximately 50microliter) of blood within one minute.

    approximately 6 months

Secondary Outcomes (1)

  • Reduction in pain

    approximately 6 months

Interventions

Rapid RingDEVICE

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

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is healthy
  • Subject's age is between 18 to 70 years old
  • Subject must be capable of providing informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

Study Officials

  • Ella Naparstek, Prof.

    Chairman of the Hematology Institute and the Department of Hematology and Bone Marrow Transplantation at Tel Aviv Sourasky Medical Center.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Boris Tartakovsky, PhD

CONTACT

boris.tartakovsky@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 27, 2010

First Posted

June 29, 2010

Study Start

August 1, 2010

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

June 29, 2010

Record last verified: 2010-06

Locations

IL(1)