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

NCT04915495

NAINTERVENTIONAL

Guided Therapeutics

400 participants

Started 2023-05-05 · Completed 2025-07-31

Status: Enrolling By Invitation (as of 12-23-2025)

Conditions

Cervical Dysplasia

Interventions

DIAGNOSTIC_TEST: LuViva Advanced Cervical Scan

Linked Papers (from SciSciNet-V2)

Total Papers20

Background

7

Result

0

Derived

0

Unknown

13

View on ClinicalTrials.gov

Total Citations Per Year

Brief 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.

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Background Papers13

Multiple Biopsies and Detection of Cervical Cancer Precursors at Colposcopy

Multiple Biopsies and Detection of Cervical Cancer Precursors at Colposcopy

2019 ASCCP Risk-Based Management Consensus Guidelines: Methods for Risk Estimation, Recommended Management, and Validation

2019 ASCCP Risk-Based Management Consensus Guidelines: Methods for Risk Estimation, Recommended Management, and Validation

ASCCP Colposcopy Standards: How Do We Perform Colposcopy? Implications for Establishing Standards

ASCCP Colposcopy Standards: How Do We Perform Colposcopy? Implications for Establishing Standards

Colposcopy and additive diagnostic value of biopsies from colposcopy‐negative areas to detect cervical dysplasia

Colposcopy and additive diagnostic value of biopsies from colposcopy‐negative areas to detect cervical dysplasia

Observed Colposcopy Practice in US Community-Based Clinics: The Retrospective Control Arm of the IMPROVE-COLPO Study

Observed Colposcopy Practice in US Community-Based Clinics: The Retrospective Control Arm of the IMPROVE-COLPO Study

Pooled analysis on the necessity of random 4-quadrant cervical biopsies and endocervical curettage in women with positive screening but negative colposcopy

Pooled analysis on the necessity of random 4-quadrant cervical biopsies and endocervical curettage in women with positive screening but negative colposcopy

Identifying a “Range of Reasonable Options” for Cervical Cancer Screening

Result Papers0

No result papers linked

Derived Papers0

No derived papers linked

Unknown Papers13

Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries

74,955 citations

2001 Consensus Guidelines for the Management of Women With Cervical Cytological Abnormalities

1,232 citations

Colposcopy for the diagnosis of squamous intraepithelial lesions: A meta-analysis

Number of Cervical Biopsies and Sensitivity of Colposcopy

Effects of Age and Human Papilloma Viral Load on Colposcopy Triage: Data From the Randomized Atypical Squamous Cells of Undetermined Significance/Low-Grade Squamous Intraepithelial Lesion Triage Study (ALTS)

Strength of correlations between colposcopic impression and biopsy histology

The accuracy of colposcopic biopsy: Analyses from the placebo arm of the Gardasil clinical trials

Evidence-Based Consensus Recommendations for Colposcopy Practice for Cervical Cancer Prevention in the United States

Utility of Random Cervical Biopsy and Endocervical Curettage in a Low-Risk Population

Random Biopsy After Colposcopy-Directed Biopsy Improves the Diagnosis of Cervical Intraepithelial Neoplasia Grade 2 or Worse

The increased detection of cervical intraepithelial neoplasia when using a second biopsy at colposcopy

Multimodal hyperspectroscopy as a triage test for cervical neoplasia: Pivotal clinical trial results

Colposcopy at a Crossroads