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A Study to Evaluate the Performance, Usability, and Contrived Result Interpretation of iStatis Gonorrhea Antigen Test

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Sep 1, 2026 → Dec 1, 2026
See other at-risk trials from bioLytical Laboratories

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Sep 1, 2026 to Dec 1, 2026
    • Eligibility criteria expanded, about 30 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description expanded, about 3 words
  2. Re-verified, no change to tracked fieldsv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The objective of this study is to evaluate the performance, usability, and contrived result interpretation of iStatis Gonorrhea Antigen Test (iStatis Gonorrhea Test) in the intended near-patient or point-of-care setting by trained personnel.
Trial Details
NCT Number NCT07569900
Lead Sponsor bioLytical Laboratories
Collaborators: Epicentre
Conditions
(from sponsor)		 Gonorrhea Infection
Enrollment 650 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov