Safety and Performance Evaluation of the Rapid Ring Device

RapiDx

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Healthy

Treatments

Device: Rapid Ring

Study type

Interventional

Funder types

Industry

Identifiers

NCT01152983

CTIL - CL-001

Details and patient eligibility

About

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

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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