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

NCT04915495 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2025-03-21

No results posted yet for this study

Summary

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.

Conditions

  • Cervical Dysplasia

Interventions

DIAGNOSTIC_TEST

LuViva Advanced Cervical Scan

Multimodal hyperspectral device

Sponsors & Collaborators

  • Guided Therapeutics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-05
Primary Completion
2025-07-31
Completion
2025-07-31
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 NCT04915495 on ClinicalTrials.gov