SAVI SCOUT Clinical Evaluation Study

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

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.

Study Overview

• Status: Unknown
• Conditions: Breast Neoplasm
• Intervention / Treatment: Device: Localization of breast lesion

Detailed Description

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
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cianna Medical, Inc.
• Collaborators: University of South Florida
• Investigators: Principal Investigator: Charles Cox, MD, University of South Florida

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Anticipated): August 1, 2015
• Study Completion (Anticipated): August 1, 2015

Study Registration Dates

• First Submitted: February 2, 2015
• First Submitted That Met QC Criteria: February 23, 2015
• First Posted (Estimate): February 24, 2015

Study Record Updates

• Last Update Posted (Estimate): March 9, 2015
• Last Update Submitted That Met QC Criteria: March 5, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: breast conserving surgery; lumpectomy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: Pro00019820