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(PMA withdrawn)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 (Responsible Party):
SpectraScience
ClinicalTrials.gov Identifier:
NCT00358111
First received: July 27, 2006
Last updated: May 12, 2014
Last verified: May 2014
  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 Phase
Dysplasia
Cancer
Device: Luma Cervical Imaging System
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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 ]

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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: SpectraScience
ClinicalTrials.gov Identifier: NCT00358111     History of Changes
Other Study ID Numbers: 302925
Study First Received: July 27, 2006
Last Updated: May 12, 2014
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 July 29, 2014