NCT02663635

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 26, 2016

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

Same day

First QC Date

January 7, 2016

Last Update Submit

January 26, 2016

Conditions

Needle Stick

Outcome Measures

Primary Outcomes (1)

  • 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 (4)

  • Ease of Use

    At time of testing, day 1

  • Evaluator assessment of device handling

    At time of testing, day 1

  • Evaluator assessment of instructions

    At time of testing, day 1

  • Evaluator assessment of improvement of device over predecessor device

    At time of testing, day 1

Study Arms (1)

Single Arm

OTHER
Device: Safe'N'Sound

Interventions

Safe'N'SoundDEVICE
Single Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NAMSA

Minneapolis, Minnesota, 55422, United States

Location

MeSH Terms

Conditions

Needlestick Injuries

Condition Hierarchy (Ancestors)

Wounds, StabWounds, PenetratingWounds and Injuries

Study Officials

  • Timothy Pratt

    NAMSA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2016

First Posted

January 26, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

January 28, 2016

Record last verified: 2016-01

Locations

US(1)