- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03811444
Simulated Clinical Use Testing On Safety Lancets (Test B)
Simulated Clinical Use Testing to Evaluate Sharps Injury Prevention Features of HTL-STREFA's Safety Lancets (Test A)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study aims to evaluate the safety of the use of the safety lancets: Haemolance Plus, Prolance and MediSafe Solo 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60606
- UL LLC
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02116
- Schlesinger Associates
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
The inclusion criteria for HCP and lay person evaluators have been chosen based on FDA guidance:
- 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:
Individuals will be excluded if:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: simulation of skin pricking type 420
The evaluator simulated the capillary blood sampling with the safety lancet type 420
|
Haemolance Plus safety lancet type 420 is a sterile, single use medical device designed for the sampling of capillary blood from the fingertip of patients
|
Experimental: simulation of skin pricking type 430
The evaluator simulated the capillary blood sampling with the safety lancet type 430
|
Prolance safety lancet type 430 is a sterile, single use medical device designed for the sampling of capillary blood from the fingertip of patients.
|
Experimental: simulation of skin pricking type 520
The evaluator simulated the capillary blood sampling with the safety lancet type 520
|
MediSafe Solo safety lancet type 520 is a sterile, single use medical device designed for the sampling of capillary blood from the fingertip of patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The true failure rate of the tested devices
Time Frame: At time of testing, up to 90 minutes
|
At time of testing, up to 90 minutes
|
|
Effectiveness of the safety lancet's sharps injury prevention features
Time Frame: At time of testing, up to 90 minutes
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective assessments regarding evaluators' interactions with the tested safety lancets
Time Frame: At time of testing, up to 90 minutes
|
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
|
Safety of the devices based on the evaluators' assessments (five-point response scale)
Time Frame: At time of testing, up to 90 minutes
|
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.
|
At time of testing, up to 90 minutes
|
Various aspects of the ease of use.
Time Frame: At time of testing, up to 90 minutes
|
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
|
Any handling, usability questions / issues associated with the device
Time Frame: At time of testing, up to 90 minutes
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Test B
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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