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Study of LUMA Cervical Imaging System as Adjunct to Colposcopy

This study has been terminated.
(PMA withdrawn)
ClinicalTrials.gov Identifier:
First Posted: July 28, 2006
Last Update Posted: May 13, 2014
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.
University of Iowa
Information provided by (Responsible Party):
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 Intervention Phase
Dysplasia Cancer Device: Luma Cervical Imaging System Phase 4

Study Type: Interventional
Study Design: 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

Further study details as provided by SpectraScience:

Primary Outcome Measures:
  • 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 ]

Enrollment: 10
Study Start Date: July 2006
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Luma Cervical Imaging System
    Colposcopy using LUMA Cervical Imaging System

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
  Contacts and Locations
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 ClinicalTrials.gov 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
  More Information

Responsible Party: SpectraScience
ClinicalTrials.gov Identifier: NCT00358111     History of Changes
Other Study ID Numbers: 302925
First Submitted: July 27, 2006
First Posted: July 28, 2006
Last Update Posted: May 13, 2014
Last Verified: May 2014

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