Study of LUMA Cervical Imaging System as Adjunct to Colposcopy
NCT00358111 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2014-05-13
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.
Conditions
- Dysplasia
- Cancer
Interventions
- DEVICE
-
Luma Cervical Imaging System
Colposcopy using LUMA Cervical Imaging System
Sponsors & Collaborators
-
University of Iowa
collaborator OTHER -
SpectraScience
lead OTHER
Principal Investigators
-
Jim Hitchin · SpectraScience
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- TRIPLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-07-31
- Primary Completion
- 2010-11-30
- Completion
- 2010-11-30
Countries
- United States
Study Locations
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