SAVI SCOUT Clinical Evaluation Study
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|ClinicalTrials.gov Identifier: NCT02370082|
Recruitment Status : Unknown
Verified February 2015 by Cianna Medical, Inc..
Recruitment status was: Enrolling by invitation
First Posted : February 24, 2015
Last Update Posted : March 9, 2015
The purpose of this study is to evaluate the performance of the SAVI SCOUT® Surgical Guidance System (SAVI SCOUT). The SAVI SCOUT is a medical device, used to provide real-time guidance during localized excisional biopsy or lumpectomy procedures, by helping the surgeon locate and remove the desired tissue (i.e., the lesion and surrounding normal tissue). The SAVI SCOUT has been 510K cleared.
The SAVI SCOUT is intended to assist surgeons in the location and retrieval of a non-palpable abnormality as localized by radiographic or ultrasound methods. In this study, the ability of the SAVI SCOUT to guide surgeons to find a lesion will be evaluated instead of the standard technique of wire localization.
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasm||Device: Localization of breast lesion||Not Applicable|
Using radiography or ultrasound guidance, the SAVI SCOUT reflector will be placed percutaneously up to 7 days prior to the scheduled excisional procedure. During surgical excision, the SAVI SCOUT system will be used to locate the reflector, which will be removed along with the surrounding breast tissue.
Final data analysis will be completed within 1 month after the last patient is treated.
Final assessment of the surgical results will be completed by the surgeon during a routine follow-up visit within 1 month following the surgical excision or lumpectomy procedure.
Main Objective: to show that the SAVI SCOUT technique can be used to safely and effectively locate a non-palpable breast lesion during a localized excisional biopsy or lumpectomy procedure.
Up to 10 sites and 150 patients will be enrolled.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Single-Arm, Multi-Site, Clinical Evaluation of the SAVI SCOUT® Surgical Guidance System for the Location of Non-Palpable Breast Lesions During Excision|
|Study Start Date :||February 2015|
|Estimated Primary Completion Date :||August 2015|
|Estimated Study Completion Date :||August 2015|
Experimental: SAVI SCOUT device
SAVI SCOUT device used to localize breast lesion which will then be removed surgically. The SAVI SCOUT is the intervention for localization of breast lesions.
Device: Localization of breast lesion
localization of breast lesion for removal
- Success rate of reflector placement [ Time Frame: intraoperative ]How often the reflector can be successfully placed
- Amount of tissue excised [ Time Frame: Will be assessed by pathologist during standard pathology assessment which occurs 24-48 hours after surgery ]Pathologic assessment of how much tissue was removed
- Percent of cases with clear margins • Percent of cases requiring a second operation [ Time Frame: Upon completion of pathologic assessment-which will occur within 24-48 hours after surgery ]How often patients are not required to have repeat procedures
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02370082
|Principal Investigator:||Charles Cox, MD||University of South Florida|