Study of LUMA Cervical Imaging System as Adjunct to Colposcopy

Phase 4

Terminated

• Conditions: Dysplasia; Cancer

• Registration Number: NCT00358111
• Lead Sponsor: SpectraScience

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-07-27
• Study First Submitted QC: 2006-07-27
• Study First Posted: 2006-07-28
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-12
• Last Update Posted: 2014-05-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

• Documented abnormal pap test

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Relationship between HPV and the performance of the LUMA system as an adjunct to colposcopy for detection of CIN 2,3+ will be assessed.	ongoing - estimated at 3 years

Trial Locations

Locations (2)

Women's Interventional Health; 🇺🇸 Encinitas, California, United States

U of Iowa Health Center; 🇺🇸 Iowa City, Iowa, United States