- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04933461
Simulated Clinical Use Testing to Evaluate Sharps Injury Prevention Features of HTL-STREFA's Safety Lancets (Test C)
Studieoversikt
Detaljert beskrivelse
This study aims to evaluate the safety of the use of the following safety lancets: Medlance Plus and myLance in the prevention of needle-stick injury (NSI) and to evaluate the user's opinion with regard to the handling characteristics of the medical devices.
The simulated use clinical study involves healthcare professionals (HCPs) who routinely use safety lancets to collect blood samples.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Illinois
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Chicago, Illinois, Forente stater, 60606
- Chicago office
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Massachusetts
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Boston, Massachusetts, Forente stater, 02116
- Boston office
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Annen: Simulation of skin pricking by using Medlance Plus
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.
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There are sterile, single-use safety lancets designed for the sampling of capillary blood from the fingertip of patients.
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Annen: Simulation of skin pricking by using myLance
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.
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There are sterile, single-use safety lancets designed for the sampling of capillary blood from the fingertip of patients.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
The true failure rate of the tested devices.
Tidsramme: At time of testing, up to 90 minutes
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At time of testing, up to 90 minutes
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Effectiveness of the safety lancet's sharps injury prevention features.
Tidsramme: At time of testing, up to 90 minutes
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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.
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At time of testing, up to 90 minutes
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Evaluation of the safety of the devices based on the evaluators' assessments.
Tidsramme: At time of testing, up to 90 minutes ]
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At time of testing, up to 90 minutes ]
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Evaluation of various aspects of the ease of use.
Tidsramme: At time of testing, up to 90 minutes ]
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At time of testing, up to 90 minutes ]
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Detection of any handling, usability questions / issues associated with the device.
Tidsramme: At time of testing, up to 90 minutes ]
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At time of testing, up to 90 minutes ]
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Test C
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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