Study of LUMA Cervical Imaging System as Adjunct to Colposcopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00358111
Recruitment Status : Terminated (PMA withdrawn)
First Posted : July 28, 2006
Last Update Posted : May 13, 2014
University of Iowa
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Dysplasia Cancer Device: Luma Cervical Imaging System Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Official Title: A Single Arm Multi-Center Post Approval Study of LUMA as Adjunct to Colposcopy
Study Start Date : July 2006
Primary Completion Date : November 2010
Study Completion Date : November 2010

Intervention Details:
    Device: Luma Cervical Imaging System
    Colposcopy using LUMA Cervical Imaging System

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Documented abnormal pap test

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00358111

United States, California
Women's Interventional Health
Encinitas, California, United States, 92024
United States, Iowa
U of Iowa Health Center
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Study Chair: Jim Hitchin SpectraScience

Responsible Party: SpectraScience Identifier: NCT00358111     History of Changes
Other Study ID Numbers: 302925
First Posted: July 28, 2006    Key Record Dates
Last Update Posted: May 13, 2014
Last Verified: May 2014

Keywords provided by SpectraScience:
high-grade disease
Cervical examination
targeting biopsies