Large Algorithm Setting and Validation Study

Part of paid clinical trials in New Orleans, Louisiana.

Sponsor
Nanopath, Inc
Study ID
NCT07607470
Status
Not Yet Recruiting

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Conditions

  • Bacterial Infections
  • Bacterial Infections and Mycoses
  • Candidiasis
  • Female Urogenital Diseases
  • Genital Diseases, Female
  • Infections
  • Mycoses
  • Urogenital Disease
  • Vaginal Diseases
  • Vaginitis
  • Vaginosis, Bacterial
  • Vulvar Diseases
  • Vulvovaginitis

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nanopath Vaginitis Assay — DIAGNOSTIC_TEST
    Investigational Device
  • BD Max™ Vaginal Panel — DIAGNOSTIC_TEST
    This is an FDA-cleared diagnostic test that will be used as labelled. It will serve as one of three NAAT comparators in this study.
  • Cepheid Xpert® Xpress MVP — DIAGNOSTIC_TEST
    This is an FDA-cleared diagnostic test that will be used as labelled. It will serve as one of three NAAT comparators in this study.
  • Hologic Aptima® BV Assay — DIAGNOSTIC_TEST
    This is an FDA-cleared diagnostic test that will be used as labelled. It will serve as one of three NAAT comparators in this study.
  • Yeast Culture — DIAGNOSTIC_TEST
    Culture plus use of MALDI-TOF (Matrix-Assisted Laser Desorption/Ionization Time-of-Flight mass spectrometry) for required speciation.

Study Details

In this pilot study, prospectively acquired clinician-collected and participant-collected vaginal swab specimens will be obtained from up to 1000 individuals with signs and symptoms of vaginitis to develop and validate a bacterial vaginosis diagnostic algorithm and evaluate the performance of the Nanopath assay. The Nanopath assay is an amplification-free molecular test that detects pathogens associated with vaginitis. The performance of the Nanopath assay will be assessed by comparing Nanopath assay results to previously FDA-cleared commercial tests and yeast culture.

Key Dates

Start date
May 20, 2026
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: Vaginal Infections (BV, CV, TV)

Primary Outcome Measure

Accuracy of Nanopath Assay for Diagnosis of Vaginal Infections [ Time Frame: 1 day ]

Locations (1)

FacilityCityStateZIPSite coordinators
LSU-CrescentCare Sexual Health CenterNew OrleansLouisiana70119
Catherine Cammarata
[email protected]
504-568-4132
Rebecca Lillis (PRINCIPAL_INVESTIGATOR)

Find similar trials in New Orleans, LA

By research site
LSU-CrescentCare Sexual Health Center· New Orleans, LA

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