Simulated Clinical Use Testing to Evaluate Sharps Injury Prevention Features of HTL-STREFA's Safe… (NCT04933461) | Clinical Trial Compass
CompletedNot Applicable
Simulated Clinical Use Testing to Evaluate Sharps Injury Prevention Features of HTL-STREFA's Safety Lancets (Test C)
United States20 participantsStarted 2019-09-24
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The true failure rate of the tested devices.
Timeframe: At time of testing, up to 90 minutes
2
Effectiveness of the safety lancet's sharps injury prevention features.