Simulated Clinical Use Testing on Safe'N'Sound 1ML Stalke... | NCT02663635

Studies
Simulated Clinical Use Testing on Safe'N'Sound 1ML Stalked Passive Delivery System With Add-On Extended Finger Flanges

NCT02663635

Sponsor

Nemera La Verpilliere

Status

Completed

Last Update Posted

Jan 28, 2016Estimated

Enrollment

30Actual

Phase

Phase 3

Conditions

Needle Stick

Interventions

Safe'N'Sound

Countries

United States

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

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Jan 2016Actual

Completion Date

Jan 2016Actual

First Submitted Date

Jan 7, 2016

First Submission Date that Met QC Criteria

Jan 21, 2016

First Posted Date

Jan 26, 2016Estimated

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

Jan 26, 2016

Last Update Posted Date

Jan 28, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

A simulated clinical use testing the Save'N'Sound 1mL staked Passive Delivery System with add-on extended finger flanges

Detailed Description

This study aims to evaluate the safety of the use of the Safe'N'Sound 1mL staked passive delivery system cone version with add-on EFF in the prevention of needle stick injuries and to evaluate the user's satisfaction with regards to the handling characteristics of the product namely safety, design and the ease of use.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Label	Type	Description	Intervention Names
Single Arm	Other		Device: Safe'N'Sound

Name	Type	Description	Arm Group Labels	Other Names
Safe'N'Sound	Device		Single Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The true failure rate of the Safe'n'Sound 1mL Staked Passive Delivery system with add-on extended finger flange		At time of testing, day 1

Secondary Outcomes

Measure	Description	Time Frame
Ease of Use		At time of testing, day 1
Evaluator assessment of device handling		At time of testing, day 1
Evaluator assessment of instructions

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The Evaluator must be:

Minimum of age 18
Able to understand and provide signed consent for the study
Willing to comply with the study protocol, including being willing to answer questions and complete questionnaires
Have no concerns about the ability to perform the simulated injections
With no financial interest in the sponsor (Nemera) or the CRO (NAMSA)

Exclusion Criteria:

If in the opinion of CRO, including the observer/monitor, the potential evaluator is not a good candidate for the study, including the reasons such as mental health.

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

Not provided

Overall Officials

Name	Affiliation	Role
Timothy Pratt	NAMSA	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NAMSA		Minneapolis	Minnesota	55422	United States

Condition Browse Module

MeSH Terms

ID	Term
D016602	Needlestick Injuries

Ancestor Terms

ID	Term
D014951	Wounds, Stab
D014950	Wounds, Penetrating
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided