Study of LUMA Cervical Imaging System as Adjunct to Colposcopy
This study has been terminated.
(PMA withdrawn)
Sponsor:
SpectraScience
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
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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 May 19, 2013