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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03807635
Other study ID # Test A
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 30, 2018
Est. completion date December 13, 2018

Study information

Verified date January 2019
Source HTL-Strefa S.A.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

This study aims to evaluate the safety of the use of the safety lancets: ergoLance and Acti-Lance 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 and lay persons.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date December 13, 2018
Est. primary completion date December 13, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

The inclusion criteria for HCP and lay person evaluators have been chosen based on FDA guidance:

- (HCP evaluators only) - 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.

Lay person evaluators will have a diverse range of ages (18+ years), socioeconomic statuses, and race/ethnic backgrounds. UL-Wiklund will recruit some lay person evaluators with reduced vision and dexterity. Users without safety lancet experience may also be included in this simulated clinical use study.

Exclusion Criteria:

HCPs:

- 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 or marketing study involving safety lancets within the last six months

Lay people:

- 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 or marketing study involving safety lancets within the last six months

Study Design


Related Conditions & MeSH terms


Intervention

Device:
ergoLance safety lancet
The ergoLance contact activated safety lancets type 450 are sterile, single-use safety lancets designed for the sampling of capillary blood from the fingertip of patients.
Acti-Lance safety lancet
The Acti-Lance safety lancet type 610 is a sterile, single use device used to carry out skin punctures for the purpose of collecting capillary blood samples.

Locations

Country Name City State
United States Schlesinger Associates Boston Massachusetts
United States UL LLC Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
HTL-Strefa S.A.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The true failure rate of the tested devices At time of testing, up to 90 minutes
Primary 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 Subjective assessments regarding evaluators' interactions with the tested safety lancets 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 Safety of the devices based on the evaluators' assessments (five-point response scale) 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
Secondary Various aspects of the ease of use. 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 Any handling, usability questions / issues associated with the device 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
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