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(PMA withdrawn)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
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 27, 2006 | ||||
| Last Updated Date | December 8, 2010 | ||||
| Start Date ICMJE | July 2006 | ||||
| Primary Completion Date | November 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00358111 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Diagnostic |
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| Condition ICMJE |
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| Intervention ICMJE | Device: Luma Cervical Imaging System
Colposcopy using LUMA Cervical Imaging System |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | Not Provided | ||||
| Completion Date | November 2010 | ||||
| Primary Completion Date | November 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00358111 | ||||
| Other Study ID Numbers ICMJE | 302925 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | James Dorst, COO, SpectraScience, Inc | ||||
| Study Sponsor ICMJE | SpectraScience | ||||
| Collaborators ICMJE | University of Iowa | ||||
| Investigators ICMJE |
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| Information Provided By | SpectraScience | ||||
| Verification Date | December 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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