Back to resultsSimulated Clinical Use Testing to Evaluate Sharps Injury Prevention Features of HTL-STREFA's Safety Lancets (Test C)
Primary Purpose
Accident Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Safety lancet
Sponsored by
About this trial
This is an interventional other trial for Accident Injury focused on measuring safety lancet, capillary blood sampling, accidental needle-stick injury
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- evaluators who do not routinely use safety lancets to collect capillary blood samples,
- evaluators who cannot read, write, and speak English,
- evaluators or a family member have a business or consulting relationship with a pharmaceutical or medical device company, or
- evaluators who have participated in a product evaluation or marketing study involving safety lancets within the last six months
Sites / Locations
- Chicago office
- Boston office
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Simulation of skin pricking by using Medlance Plus
Simulation of skin pricking by using myLance
Arm Description
Estimation of the true failure rate of the device. Estimation of the sharps' injury prevention feature of the tested safety lancets are effective in preventing needle stick injuries.
Estimation of the true failure rate of the device. Estimation of the sharps' injury prevention feature of the tested safety lancets are effective in preventing needle stick injuries.
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
Evaluation of the safety of the devices based on the evaluators' assessments.
Evaluation of various aspects of the ease of use.
Detection of any handling, usability questions / issues associated with the device.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04933461
Brief Title
Simulated Clinical Use Testing to Evaluate Sharps Injury Prevention Features of HTL-STREFA's Safety Lancets (Test C)
Official Title
Simulated Clinical Use Testing to Evaluate Sharps Injury Prevention Features of HTL-STREFA's Safety Lancets (Test C)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
September 24, 2019 (Actual)
Primary Completion Date
September 24, 2019 (Actual)
Study Completion Date
September 27, 2019 (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
Yes
5. Study Description
Brief Summary
A simulated clinical use testing to evaluate the Medlance Plus and myLance sharps injury prevention feature in accordance with the FDA's guidance on medical devices with sharps injury prevention features.
Detailed Description
This study aims to evaluate the safety of the use of the following safety lancets: Medlance Plus and myLance in the prevention of needle-stick injury (NSI) and to evaluate the user's opinion with regard to the handling characteristics of the medical devices.
The simulated use clinical study involves healthcare professionals (HCPs) who routinely use safety lancets to collect blood samples.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Accident Injury
Keywords
safety lancet, capillary blood sampling, accidental needle-stick injury
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 by using Medlance Plus
Arm Type
Other
Arm Description
Estimation of the true failure rate of the device. Estimation of the sharps' injury prevention feature of the tested safety lancets are effective in preventing needle stick injuries.
Arm Title
Simulation of skin pricking by using myLance
Arm Type
Other
Arm Description
Estimation of the true failure rate of the device. Estimation of the sharps' injury prevention feature of the tested safety lancets are effective in preventing needle stick injuries.
Intervention Type
Device
Intervention Name(s)
Safety lancet
Intervention Description
There are sterile, single-use safety lancets designed for the sampling of capillary blood from the fingertip of patients.
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
Evaluation of the safety of the devices based on the evaluators' assessments.
Time Frame
At time of testing, up to 90 minutes ]
Title
Evaluation of various aspects of the ease of use.
Time Frame
At time of testing, up to 90 minutes ]
Title
Detection of any handling, usability questions / issues associated with the device.
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:
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.
Exclusion Criteria:
evaluators who do not routinely use safety lancets to collect capillary blood samples,
evaluators who cannot read, write, and speak English,
evaluators or a family member have a business or consulting relationship with a pharmaceutical or medical device company, or
evaluators who have participated in a product evaluation or marketing study involving safety lancets within the last six months
Facility Information:
Facility Name
Chicago office
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60606
Country
United States
Facility Name
Boston office
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02116
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Simulated Clinical Use Testing to Evaluate Sharps Injury Prevention Features of HTL-STREFA's Safety Lancets (Test C)
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