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NCT01733069 · ClinicalTrials.gov registry record

Clinical Evaluation of the APTIMA® COMBO 2® Assay Using the PANTHER™ System

A clinical trial, sponsored by Gen-Probe, Incorporated.

Completed
Registry status
1,912
Enrollment target

NCT01733069: Completed study, sponsored by Gen-Probe, Incorporated.

NCT01733069 is a clinical trial that has completed, run by Gen-Probe, Incorporated. The registered enrollment target is 1,912 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01733069 has completed, sponsored by Gen-Probe, Incorporated.

COMPLETED
Registry status
1,912 participants
Enrollment target

Study Summary

The objectives of this study are to establish the performance characteristics of the AC2 (APTIMA Combo 2) Assay on the PANTHER System for the sample types cleared for use on the TIGRIS and DTS (Direct Tube Sampling) Systems and to demonstrate the repeatability and reproducibility of the AC2 Assay on the PANTHER System.

Primary Outcome

Count of participants having a positive or negative APTIMA Combo 2 assay result (sensitivity and specificity)

Interventions

  • DEVICE APTIMA COMBO 2 Assay (AC2 Assay)

Trial Details

FieldValue
Enrollment Target 1,912 participants
Start Date 2010-11
Est. Completion 2012-02
Gen-Probe, Incorporated

12 total trials

What the finished NCT01733069 record still lists

NCT01733069 is an observational study that tracks outcomes without assigning an intervention. Its 1,912 participants enrollment target places it among the larger protocols in the corpus.

The record links to 0 conditions, and to 1 intervention - of which APTIMA COMBO 2 Assay (AC2 Assay) is the first listed.

NCT01733069 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01733069 about?

NCT01733069 is a clinical study titled "Clinical Evaluation of the APTIMA® COMBO 2® Assay Using the PANTHER™ System". The objectives of this study are to establish the performance characteristics of the AC2 (APTIMA Combo 2) Assay on the PANTHER System for the sample types cleared for use on the TIGRIS and DTS (Direct Tube Sampling) Systems and to demonstrate the repeatability and reproducibility of the AC2 Assay on...

What is the current status of trial NCT01733069?

This trial is currently completed. The enrollment target is 1,912 participants. The study started on 2010-11. Estimated completion is 2012-02.

What interventions are being tested in trial NCT01733069?

The interventions under investigation include: APTIMA COMBO 2 Assay (AC2 Assay) (DEVICE).

Who is sponsoring clinical trial NCT01733069?

This trial is sponsored by Gen-Probe, Incorporated, which has 12 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01733069, the US trial registry maintained by the National Library of Medicine. NCT01733069 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.