SAVI SCOUT Clinical Evaluation Study

Cianna Medical, Inc.150 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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: \-

Outcomes

Primary Outcomes

Success rate of reflector placement

How often the reflector can be successfully placed

Time frame: intraoperative

Secondary Outcomes

Amount of tissue excised

Pathologic assessment of how much tissue was removed

Time frame: 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

Time frame: Upon completion of pathologic assessment-which will occur within 24-48 hours after surgery