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Study of LUMA Cervical Imaging System as Adjunct to Colposcopy

Cancer Clinical Trial

Official title:
A Single Arm Multi-Center Post Approval Study of LUMA as Adjunct to Colposcopy

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00358111
Study type Interventional
Source SpectraScience
Contact
Status Terminated
Phase Phase 4
Start date July 2006
Completion date November 2010
View Details
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