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Study of LUMA Cervical Imaging System as Adjunct to Colposcopy

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ClinicalTrials.gov Identifier: NCT00358111
Recruitment Status : Terminated (PMA withdrawn)
First Posted : July 28, 2006
Last Update Posted : May 13, 2014
Sponsor:
Collaborator:
University of Iowa
Information provided by (Responsible Party):
SpectraScience

Study Description
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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 Design
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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
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010
Arms and Interventions
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Intervention Details:
  • Device: Luma Cervical Imaging System
    Colposcopy using LUMA Cervical Imaging System

Outcome Measures
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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 ]

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

Inclusion Criteria:

  • Documented abnormal pap test
Contacts and Locations
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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


Locations
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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
SpectraScience
University of Iowa
Investigators
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Study Chair: Jim Hitchin SpectraScience
More Information
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Responsible Party: SpectraScience
ClinicalTrials.gov Identifier: NCT00358111    
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
dysplasia
cancer