search
Back to results

Simulated Clinical Use Testing on Safety Lancets (Test A)

Primary Purpose

Needle Stick

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ergoLance safety lancet
Acti-Lance safety lancet
Sponsored by
HTL-Strefa S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Needle Stick focused on measuring needlestick, needlestick injury, safety lancet, sharps injury prevention, capillary blood sampling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

The inclusion criteria for HCP and lay person evaluators have been chosen based on FDA guidance:

  • (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.

Exclusion Criteria:

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

Sites / Locations

  • UL LLC
  • Schlesinger Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

simulation of skin pricking type 450

simulation of skin pricking type 610

Arm Description

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

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

Outcomes

Primary Outcome Measures

The true failure rate of the tested devices
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.

Secondary Outcome Measures

Subjective assessments regarding evaluators' interactions with the tested safety lancets
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.
Safety of the devices based on the evaluators' assessments (five-point response scale)
Evaluator questionnaire using five-point response Likert scale (coded from 1 "strongly disagree" to 5 "strongly agree") to measure any and all observed needlestick injuries and device malfunctions. Numbers assigned to Likert scale express a "greater than" relationship.
Various aspects of the ease of use.
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.
Any handling, usability questions / issues associated with the device
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.

Full Information

First Posted
January 10, 2019
Last Updated
January 18, 2019
Sponsor
HTL-Strefa S.A.
search

1. Study Identification

Unique Protocol Identification Number
NCT03807635
Brief Title
Simulated Clinical Use Testing on Safety Lancets (Test A)
Official Title
Simulated Clinical Use Testing to Evaluate Sharps Injury Prevention Features of HTL-STREFA's Safety Lancets (Test A)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
November 30, 2018 (Actual)
Primary Completion Date
December 13, 2018 (Actual)
Study Completion Date
December 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HTL-Strefa S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A simulated clinical use testing on the HTL-Strefa's safety lancets
Detailed Description
This study aims to evaluate the safety of the use of the safety lancets: ergoLance and Acti-Lance in the prevention of NSI and to evaluate the user's opinion with regards to the handling characteristics of the medical devices. The simulated use clinical study will involve healthcare professionals (HCPs) who routinely use safety lancets to collect blood samples and lay persons.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Needle Stick
Keywords
needlestick, needlestick injury, safety lancet, sharps injury prevention, capillary blood sampling

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
simulation of skin pricking type 450
Arm Type
Experimental
Arm Description
The evaluator simulated the capillary blood sampling with the safety lancet type 450
Arm Title
simulation of skin pricking type 610
Arm Type
Experimental
Arm Description
The evaluator simulated the capillary blood sampling with the safety lancet type 610
Intervention Type
Device
Intervention Name(s)
ergoLance safety lancet
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Acti-Lance safety lancet
Intervention Description
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.
Primary Outcome Measure Information:
Title
The true failure rate of the tested devices
Time Frame
At time of testing, up to 90 minutes
Title
Effectiveness of the safety lancet's sharps injury prevention features
Description
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.
Time Frame
At time of testing, up to 90 minutes
Secondary Outcome Measure Information:
Title
Subjective assessments regarding evaluators' interactions with the tested safety lancets
Description
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.
Time Frame
At time of testing, up to 90 minutes
Title
Safety of the devices based on the evaluators' assessments (five-point response scale)
Description
Evaluator questionnaire using five-point response Likert scale (coded from 1 "strongly disagree" to 5 "strongly agree") to measure any and all observed needlestick injuries and device malfunctions. Numbers assigned to Likert scale express a "greater than" relationship.
Time Frame
At time of testing, up to 90 minutes
Title
Various aspects of the ease of use.
Description
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.
Time Frame
At time of testing, up to 90 minutes
Title
Any handling, usability questions / issues associated with the device
Description
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.
Time Frame
At time of testing, up to 90 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The inclusion criteria for HCP and lay person evaluators have been chosen based on FDA guidance: (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. Exclusion Criteria: 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
Facility Information:
Facility Name
UL LLC
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60606
Country
United States
Facility Name
Schlesinger Associates
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02116
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Simulated Clinical Use Testing on Safety Lancets (Test A)

We'll reach out to this number within 24 hrs