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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Recruitment Status : Terminated (PMA withdrawn)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

Tracking Information
First Submitted Date  ICMJE July 27, 2006
First Posted Date  ICMJE July 28, 2006
Last Update Posted Date May 13, 2014
Study Start Date  ICMJE July 2006
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2010)
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 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of LUMA Cervical Imaging System as Adjunct to Colposcopy
Official Title  ICMJE A Single Arm Multi-Center Post Approval Study of LUMA as Adjunct to Colposcopy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Dysplasia
  • Cancer
Intervention  ICMJE Device: Luma Cervical Imaging System
Colposcopy using LUMA Cervical Imaging System
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 12, 2014)
10
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Documented abnormal pap test
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00358111
Other Study ID Numbers  ICMJE 302925
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party SpectraScience
Study Sponsor  ICMJE SpectraScience
Collaborators  ICMJE University of Iowa
Investigators  ICMJE
Study Chair: Jim Hitchin SpectraScience
PRS Account SpectraScience
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP