NCT06492018|Not Yet Recruiting
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Sponsor study identifier
observational
150
1 country
1
Study Start
December 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
March 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This study is part of the performance evaluation to support the conformity assessment procedure for the use of fingerstick whole blood samples with Abbott's Panbio™ HCV Self Test device, as performed by lay users. The study will be conducted in accordance with the Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council and, to provide data to demonstrate the product is safe and effective for its intended use.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 16, 2024
Actual (reported)July 9, 2024
Actual (reported)December 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Lay user / professional user test result concordance
To assess the concordance between the Panbio™ HCV Self Test, as performed by lay users based on self-collected finger-stick samples, and the Panbio™ HCV Self Test performed by a trained health care worker, who also will collect the finger-stick sample required for the test and perform the test.
5 months
Lay user / laboratory test result concordance
To establish clinical performance (concordance with the reference test) for the Panbio™ HCV Self Test, as performed by lay users using finger-stick whole blood samples, when compared to reference testing using venous plasma samples.
5 months
Labelling comprehension evaluation
5 months
Results interpretation evaluation
5 months
Usability evaluation - lay user experience
5 months
Usability evaluation - Self-test observer records
5 months
Lay user / professional user results interpretation concordance
5 months
Rapid diagnostic test (self-test and professional) plus laboratory reference tests
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Participants with any known or suspected anti-HCV status may be enrolled.
Hospital Universitario infanta Leonor
Madrid, 28031, Spain
Pablo Ryan, MD, PhD
Hospital Universitario Infanta Leonor
First Submitted
May 16, 2024
First Posted
July 9, 2024
Study Start
December 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
March 30, 2025
Estimated (date passed)Hepatitis C Prevalence in Men Who Have Sex With Men
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 22, 2024
Record last verified: 2024-11
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Source: ClinicalTrials.gov.
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