Safety and Performance Evaluation of the Rapid Ring Device

Healthy Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01152983
• Other study ID #: CTIL - CL-001
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: June 27, 2010
• Last updated: June 28, 2010
• Start date: August 2010
• Est. completion date: November 2010

Study information

• Verified date: June 2010
• Source: RapiDx Ltd.
• Contact: Boris Tartakovsky, PhD
• Email: boris.tartakovsky[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Israel	Tel-Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
RapiDx Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collection of at least 2 drops (approximately 50microliter) of blood within one minute.		approximately 6 months	No
Secondary	Reduction in pain		approximately 6 months	No