SAVI SCOUT Clinical Evaluation Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Breast Neoplasm

Intervention / Treatment
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* Device: Localization of breast lesion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Patient has a non-palpable breast lesion that requires excision Lesion depth ≤ 3 cm from the skin surface in the supine position Patient is scheduled for excision or BCT at a participating institution Patient is between the ages of 18 and 90 years Patient is female Patient is willing and able to comply with all study procedures and be available to follow-up for the duration of the study For lesions requiring multiple reflectors for localization, they must allow for reflectors to be placed ≥ 1cm from one another relative to the coronal plane Subject Exclusion Criteria An individual who meets any of the following criteria will be excluded from participation in this study: Patient had a previous ipsilateral breast cancer Patient has multicentric breast cancer Patient has Stage IV breast cancer Patient has been treated with neoadjuvant chemotherapy Patient is pregnant or lactating Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAVI SCOUT device<br>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<br>* localization of breast lesion for removal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of reflector placement | How often the reflector can be successfully placed | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of tissue excised | Pathologic assessment of how much tissue was removed | Will be assessed by pathologist during standard pathology assessment which occurs 24-48 hours after surgery | 
| Percent of cases with clear margins • Percent of cases requiring a second operation | How often patients are not required to have repeat procedures | Upon completion of pathologic assessment-which will occur within 24-48 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast conserving surgery, lumpectomy