Safety and Performance Evaluation of the Rapid Ring Device | NCT01152983

Studies
Safety and Performance Evaluation of the Rapid Ring Device

NCT01152983

Sponsor

RapiDx Ltd.

Status

Unknown status

Last Update Posted

Jun 29, 2010Estimated

Enrollment

30Estimated

Phase

Phase 1Phase 2

Conditions

Healthy

Interventions

Rapid Ring

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2010

Primary Completion Date

Nov 2010Estimated

Completion Date

Nov 2010Estimated

First Submitted Date

Jun 27, 2010

First Submission Date that Met QC Criteria

Jun 28, 2010

First Posted Date

Jun 29, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 28, 2010

Last Update Posted Date

Jun 29, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rapid Ring	Device	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Reduction in pain		approximately 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Boris Tartakovsky, PhD	Contact			boris.tartakovsky@gmail.com

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tel-Aviv Sourasky Medical Center		Tel Aviv			Israel