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)

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01152983

Enrollment

Registered

2010-06-29

Start date

2010-08-31

Completion date

2010-11-30

Last updated

2010-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Finger sticks, Rapid Ring, Finger sticks method of obtaining blood for diagnostic testing

Brief summary

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

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.

Interventions

DEVICERapid 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Collection of at least 2 drops (approximately 50microliter) of blood within one minute.	approximately 6 months

Secondary

Measure	Time frame
Reduction in pain	approximately 6 months

Countries

Israel

Contacts

Primary ContactBoris Tartakovsky, PhD

boris.tartakovsky@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026