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NCT00358111 Clinical Trial

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 Details — Status: Terminated

Administrative data
NCT number NCT00358111
Other study ID # 302925
Secondary ID
Status Terminated
Phase Phase 4
First received July 27, 2006
Last updated May 12, 2014
Start date July 2006
Est. completion date November 2010

Study information
Verified date May 2014
Source SpectraScience
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

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.

Recruitment information / eligibility
Status Terminated
Enrollment 10
Est. completion date November 2010
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Documented abnormal pap test

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

Intervention

Device:
• Luma Cervical Imaging System
Colposcopy using LUMA Cervical Imaging System

Locations
Country Name City State
United States Women's Interventional Health Encinitas California
United States U of Iowa Health Center Iowa City Iowa

Sponsors (2)
Lead Sponsor Collaborator
SpectraScience University of Iowa

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
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