SAVI SCOUT Clinical Evaluation Study

Breast Neoplasm Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02370082
• Other study ID #: Pro00019820
• Status: Enrolling by invitation
• Phase: N/A
• First received: February 2, 2015
• Last updated: March 5, 2015
• Start date: February 2015
• Est. completion date: August 2015

Study information

• Verified date: February 2015
• Source: Cianna Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms

Intervention

Device:
• Localization of breast lesion
localization of breast lesion for removal

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Cianna Medical, Inc.	University of South Florida

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of reflector placement	How often the reflector can be successfully placed	intraoperative	No
Secondary	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	No
Secondary	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	No