NeuMoDx PrEDiCTiNG Study Evaluation Plan

Completed · Not applicable

Conditions studied: Chlamydia Trachomatis Infection, Neisseria Gonorrheae Infection

In brief

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).

Key facts

Study ID

NCT03970850

Run by

NeuMoDx Molecular, Inc.

People needed

4017

Starts

2019-07-22

Expected to finish

2020-02-25

Last updated by the study team

2020-06-12

Who can join

Age: 14 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male and female subjects of at least 14 years of age or older.
• Subject must be able and willing to provide informed consent. The use of a 'surrogate' or 'Legally Authorized Representative' is allowed and shall follow the site's standard procedures, under which the clinical investigation will be conducted.
• Subjects undergoing a routine pelvic examination, subjects eligible for screening evaluations for possible STDs and/or subjects known to be partners with a person with a confirmed or suspected STD.
• Subject is willing to provide all required specimens.

You may not qualify if…

• Female subject reports that she had a hysterectomy.
• Subject self-reports use of antibiotics within 28 days of study enrollment.

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Healthcare Clinical Date, Inc. (Segal Trials) — North Miami, Florida, United States
• Planned Parenthood - Southwest and Central Florida — Orlando, Florida, United States
• Planned Parenthood - Southwest and Central Florida — Tampa, Florida, United States
• Indiana University (IU) — Indianapolis, Indiana, United States
• LSU Health Science — New Orleans, Louisiana, United States
• NeuMoDx Molecular, Inc. — Ann Arbor, Michigan, United States
• Henry Ford Health System (HFHS) — Detroit, Michigan, United States
• Planned Parenthood - Northern, Central and Southern New Jersey — Elizabeth, New Jersey, United States
• Planned Parenthood - Northern, Central and Southern New Jersey — Newton, New Jersey, United States
• Planned Parenthood - Northern, Central and Southern New Jersey — Riverside Park, New Jersey, United States
• TriCore Reference Labs — Albuquerque, New Mexico, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• Medical University of South Carolina (MUSC) — Charleston, South Carolina, United States
• Planned Parenthood - Gulf Coast — Houston, Texas, United States

Full record on ClinicalTrials.gov

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