Study of LUMA Cervical Imaging System as Adjunct to Colposcopy

This study has been terminated.
(PMA withdrawn)
Sponsor:
Collaborator:
University of Iowa
Information provided by:
SpectraScience
ClinicalTrials.gov Identifier:
NCT00358111
First received: July 27, 2006
Last updated: December 8, 2010
Last verified: December 2010
  Purpose

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
Dysplasia
Cancer
Device: Luma Cervical Imaging System

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
Official Title: A Single Arm Multi-Center Post Approval Study of LUMA as Adjunct to Colposcopy

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented abnormal pap test
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00358111

Locations
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
Study Chair: Jim Hitchin SpectraScience
  More Information

No publications provided

Responsible Party: James Dorst, COO, SpectraScience, Inc
ClinicalTrials.gov Identifier: NCT00358111     History of Changes
Other Study ID Numbers: 302925
Study First Received: July 27, 2006
Last Updated: December 8, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014