Simulated Clinical Use Testing to Evaluate Sharps Injury Prevention Features of HTL-STREFA's Safety Lancets (Test C)

NCT04933461 | Completed DMC

• 1 other identifier: Test C
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Accident Injury

Keywords

safety lancet; capillary blood sampling; accidental needle-stick injury

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 (3)

• Evaluation of the safety of the devices based on the evaluators' assessments.

  At time of testing, up to 90 minutes ]

• Evaluation of various aspects of the ease of use.

  At time of testing, up to 90 minutes ]

• Detection of any handling, usability questions / issues associated with the device.

  At time of testing, up to 90 minutes ]

Study Arms (2)

Simulation of skin pricking by using Medlance Plus

OTHER

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.

Device: Safety lancet

Simulation of skin pricking by using myLance

OTHER

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.

Device: Safety lancet

Interventions

Safety lancet DEVICE

There are sterile, single-use safety lancets designed for the sampling of capillary blood from the fingertip of patients.

Simulation of skin pricking by using Medlance Plus; Simulation of skin pricking by using myLance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• HTL-Strefa S.A.: lead

Study Sites (2)

Chicago office

Chicago, Illinois, 60606, United States

Location

Boston office

Boston, Massachusetts, 02116, United States

Location

MeSH Terms

Conditions

Accidental Injuries

Condition Hierarchy (Ancestors)

Wounds 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: June 9, 2021
• First Posted: June 21, 2021
• Study Start: September 24, 2019
• Primary Completion: September 24, 2019
• Study Completion: September 27, 2019
• Last Updated: June 21, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)