NCT03807635

Brief Summary

A simulated clinical use testing on the HTL-Strefa's safety lancets

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

2 active sites

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

November 30, 2018

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2018

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 17, 2019

Completed
Last Updated

January 22, 2019

Status Verified

January 1, 2019

Enrollment Period

13 days

First QC Date

January 10, 2019

Last Update Submit

January 18, 2019

Conditions

Needle Stick

Keywords

needlestickneedlestick injurysafety lancetsharps injury preventioncapillary blood sampling

Outcome Measures

Primary Outcomes (2)

  • The true failure rate of the tested devices

    At time of testing, up to 90 minutes

  • Effectiveness of the safety lancet's sharps injury prevention features

    Evaluator questionnaire using five-point response Likert scale (coded from 1 "strongly disagree" to 5 "strongly agree") to measure respondents' attitudes to a particular question or statement. Numbers assigned to Likert scale express a "greater than" relationship.

    At time of testing, up to 90 minutes

Secondary Outcomes (4)

  • Subjective assessments regarding evaluators' interactions with the tested safety lancets

    At time of testing, up to 90 minutes

  • Safety of the devices based on the evaluators' assessments (five-point response scale)

    At time of testing, up to 90 minutes

  • Various aspects of the ease of use.

    At time of testing, up to 90 minutes

  • Any handling, usability questions / issues associated with the device

    At time of testing, up to 90 minutes

Study Arms (2)

simulation of skin pricking type 450

EXPERIMENTAL

The evaluator simulated the capillary blood sampling with the safety lancet type 450

Device: ergoLance safety lancet

simulation of skin pricking type 610

EXPERIMENTAL

The evaluator simulated the capillary blood sampling with the safety lancet type 610

Device: Acti-Lance safety lancet

Interventions

ergoLance safety lancetDEVICE

The ergoLance contact activated safety lancets type 450 are sterile, single-use safety lancets designed for the sampling of capillary blood from the fingertip of patients.

simulation of skin pricking type 450
Acti-Lance safety lancetDEVICE

The Acti-Lance safety lancet type 610 is a sterile, single use device used to carry out skin punctures for the purpose of collecting capillary blood samples.

simulation of skin pricking type 610

Eligibility Criteria

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

You may qualify if:

  • (HCP evaluators only) - evaluators who routinely use safety lancets to collect capillary blood samples (prevention of the learning curve artifacts)
  • evaluators will be United States (US) residents
  • evaluators can read, write, and speak English
  • evaluators are at least 18 years old
  • evaluators are able to understand and provide signed consent for the study
  • evaluators are willing to comply with the study protocol, including being willing to answer questions and complete questionnaires.
  • evaluators have no concerns about the ability to perform the simulated skin pricking.
  • Lay person evaluators will have a diverse range of ages (18+ years), socioeconomic statuses, and race/ethnic backgrounds. UL-Wiklund will recruit some lay person evaluators with reduced vision and dexterity. Users without safety lancet experience may also be included in this simulated clinical use study.

You may not qualify if:

  • HCPs:
  • They do not routinely use safety lancets to collect capillary blood samples,
  • They cannot read, write, and speak English,
  • They or a family member have a business or consulting relationship with a pharmaceutical or medical device company, or
  • They have participated in a product evaluation or marketing study involving safety lancets within the last six months
  • Lay people:
  • They cannot read, write, and speak English,
  • They or a family member have a business or consulting relationship with a pharmaceutical or medical device company, or
  • They have participated in a product evaluation or marketing study involving safety lancets within the last six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UL LLC

Chicago, Illinois, 60606, United States

Location

Schlesinger Associates

Boston, Massachusetts, 02116, United States

Location

MeSH Terms

Conditions

Needlestick Injuries

Condition Hierarchy (Ancestors)

Wounds, StabWounds, PenetratingWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2019

First Posted

January 17, 2019

Study Start

November 30, 2018

Primary Completion

December 13, 2018

Study Completion

December 13, 2018

Last Updated

January 22, 2019

Record last verified: 2019-01

Locations

US(2)