Fast Spectral Imaging Device for Tumor Margin Mapping
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|ClinicalTrials.gov Identifier: NCT01107080|
Recruitment Status : Completed
First Posted : April 20, 2010
Last Update Posted : February 7, 2013
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||54 participants|
|Official Title:||Fast Spectral Imaging Device for Tumor Margin Mapping|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||September 2011|
30 mastectomy, partial mastectomy, and mammoplasty samples will be analyzed to define the effective post-excision time window in which the device must be used before the results can no longer be evaluated. The mammoplasty specimens are necessary to assess normal tissue outcomes.
25 Partial Mastectomy cases will be analyzed to distinguish between different implementation methods of the technology.
- To perform a critical evaluation of the device in a practical clinical setting [ Time Frame: 2 years ](1) In order to define the effective post-excision time window in which the device must be used, which ultimately has bearings on the final product indications for use. (2)To analyze the different methods of implementation of the technology.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01107080
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Study Chair:||Nimmi Ramanujam, PhD||Duke University|