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NeuMoDx PrEDiCTiNG Study Evaluation Plan

NCT03970850 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4017

Last updated 2020-06-12

No results posted yet for this study

Summary

This investigational study will be conducted to evaluate the performance of the NeuMoDx™ CT/NG Assay on the NeuMoDx™ 288 Molecular System and NeuMoDx™ 96 Molecular System (collectively referred to as NeuMoDx™ CT/NG Assay test system).

Conditions

  • Chlamydia Trachomatis Infection
  • Neisseria Gonorrheae Infection

Interventions

DIAGNOSTIC_TEST

NeuMoDx CT/NG Assay

NeuMoDx CT/NG Assay as implemented on NeuMoDx 288 Molecular System and NeuMoDx 96 Molecular System

DIAGNOSTIC_TEST

FDA-cleared NAATs

Testing swabs and urine specimen from both male and female subjects on the FDA-cleared NAATs

Sponsors & Collaborators

  • NAMSA

    collaborator OTHER

  • NeuMoDx Molecular, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-22
Primary Completion
2020-02-25
Completion
2020-02-25
FDA Device
Yes

Countries

  • United States

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 NCT03970850 on ClinicalTrials.gov