SAVI SCOUT Clinical Evaluation Study

NCT ID: NCT02370082

Last Updated: 2015-03-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2015-08-31

Brief Summary

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

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.

Conditions

Breast Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Localization of breast lesion

Intervention Type: DEVICE

localization of breast lesion for removal

Interventions

Localization of breast lesion

localization of breast lesion for removal

Intervention Type: DEVICE

Eligibility Criteria

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

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

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of South Florida

OTHER

Sponsor Role: collaborator

Cianna Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles Cox, MD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Other Identifiers

Pro00019820

Identifier Type: -

Identifier Source: org_study_id