Simulated Clinical Use Testing On Safety Lancets (Test B)

NCT03811444 | Completed

• 1 other identifier: Test B
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

A simulated clinical use testing on the HTL-Strefa's safety lancets

Conditions

Needle Stick

Keywords

needlestick; needlestick injury; safety lancet; sharps injury prevention; capillary blood sampling

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 (4)

• Subjective assessments regarding evaluators' interactions with the tested safety lancets

  At time of testing, up to 90 minutes

• Safety of the devices based on the evaluators' assessments (five-point response scale)

  At time of testing, up to 90 minutes

• Various aspects of the ease of use.

  At time of testing, up to 90 minutes

• Any handling, usability questions / issues associated with the device

  At time of testing, up to 90 minutes

Study Arms (3)

simulation of skin pricking type 420

EXPERIMENTAL

The evaluator simulated the capillary blood sampling with the safety lancet type 420

Device: Haemolance Plus safety lancet

simulation of skin pricking type 430

EXPERIMENTAL

The evaluator simulated the capillary blood sampling with the safety lancet type 430

Device: Prolance safety lancet

simulation of skin pricking type 520

EXPERIMENTAL

The evaluator simulated the capillary blood sampling with the safety lancet type 520

Device: MediSafe Solo safety lancet

Interventions

Haemolance Plus safety lancet DEVICE

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

simulation of skin pricking type 420

Prolance safety lancet DEVICE

Prolance safety lancet type 430 is a sterile, single use medical device designed for the sampling of capillary blood from the fingertip of patients.

simulation of skin pricking type 430

MediSafe Solo safety lancet DEVICE

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.

simulation of skin pricking type 520

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:

• 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

Sponsors & Collaborators

• HTL-Strefa S.A.: lead

Study Sites (2)

UL LLC

Chicago, Illinois, 60606, United States

Location

Schlesinger Associates

Boston, Massachusetts, 02116, United States

Location

MeSH Terms

Conditions

Needlestick Injuries

Condition Hierarchy (Ancestors)

Wounds, Stab; Wounds, Penetrating; 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: January 18, 2019
• First Posted: January 22, 2019
• Study Start: November 30, 2018
• Primary Completion: December 13, 2018
• Study Completion: December 13, 2018
• Last Updated: January 22, 2019

Record last verified: 2019-01

Locations

US (2)