Study of LUMA Cervical Imaging System as Adjunct to Colposcopy

Phase 4TerminatedNCT00358111

SpectraScience10 enrolled

Overview

This is a post-approval, multi-center, single-arm study (n=950) designed to address the relationship of the LUMA device performance to patient age, patient human papillomavirus (HPV) status and colposcopist experience.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

TRIPLE

Enrollment

Conditions

Dysplasia Cancer

Interventions

Luma Cervical Imaging SystemDEVICE

Colposcopy using LUMA Cervical Imaging System

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Documented abnormal pap test

Locations (2)

Women's Interventional Health

Encinitas, California, United States

U of Iowa Health Center

Iowa City, Iowa, United States

Outcomes

Primary Outcomes

Relationship between HPV and the performance of the LUMA system as an adjunct to colposcopy for detection of CIN 2,3+ will be assessed.

Time frame: ongoing - estimated at 3 years

Data from ClinicalTrials.gov

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