The Use of the LuViva Advanced Cervical Scan to Identify Women at High-Risk for Cervical Neoplasia

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Guided Therapeutics
Study ID
NCT04915495
Status
Enrolling By Invitation

Conditions

  • Cervical Dysplasia

Eligibility Criteria

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

Interventions

  • LuViva Advanced Cervical Scan — DIAGNOSTIC_TEST
    Multimodal hyperspectral device

Study Details

This study is designed to demonstrate that a multimodal hyperspectral device (LuViva) is able to segregate women with abnormal screening tests into Low and High risk groups for the purpose of determining whether they require enhanced colposcopy and additional biopsies in order to increase detection of CIN2+ cervical disease.

Key Dates

Start date
May 5, 2023
Status verified
Mar 2025
Primary completion
Jul 31, 2025
Completion
Jul 31, 2025

Study Design

Enrollment
400 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Singe-arm Study
    Experimental device being evaluated for sensitivity and specificity.

Primary Outcome Measure

Sensitivity of Diagnostic Device [ Time Frame: up to 60 days after completion of enrollment ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of Alabama Birmingham- Heersink School of MedicineBirminghamAlabama35233-
Emory University- Winship Cancer InstituteAtlantaGeorgia30322-
Great Lakes Bay Health CentersBay CityMichigan48706-
Tidewater Clinical ResearchNorfolkVirginia23502-

Find similar trials in Birmingham, AL

By research site
University of Alabama Birmingham- Heersink School of Medicine· Birmingham, ALEmory University- Winship Cancer Institute· Atlanta, GAGreat Lakes Bay Health Centers· Bay City, MITidewater Clinical Research· Norfolk, VA

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