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

NCT07569900 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 650

Last updated 2026-07-02

No results posted yet for this study

Summary

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.

Conditions

  • Gonorrhea Infection

Interventions

DEVICE

iStatis Gonorrhea Antigen Test

Vaginal swabs are tested on the iStatis Gonorrhea Antigen Test

Sponsors & Collaborators

  • Epicentre

    collaborator OTHER

  • bioLytical Laboratories

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-26
Primary Completion
2026-09-01
Completion
2027-01-01

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07569900 on ClinicalTrials.gov