Clinical Trial Details

Overview

Research Study Summary

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

Purpose

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.

To Learn more

CW ID: 206977
Date Last Changed: April 13, 2015

Clinical Trial Snapshot

Gender
Female
Age
18 to 90 Years
Overall Status
Recruiting
Lead Sponsor
Cianna Medical, Inc.
Facility Type
N/A

Eligibility

Subject Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following 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
  • Patient has known or suspected allergic reactions to materials similar to the components of the SAVI SCOUT tissue markers:
    • Patient has any condition that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study

More Info

Further study details as provided by Cianna Medical, Inc.

Primary Outcome Measures:
Success rate of reflector placement [ Time Frame: intraoperative ]
[ Designated as safety issue: No ]
How often the reflector can be successfully placed

Secondary Outcome Measures:
Amount of tissue excised [ Time Frame: Will be assessed by pathologist during standard pathology assessment which occurs 24-48 hours after surgery ] [ Designated as safety issue: No ]
Pathologic assessment of how much tissue was removed

Percent of cases requiring a second operation [ Time Frame: Upon completion of pathologic assessment-which will occur within 24-48 hours after surgery ] [ Designated as safety issue: No ]
Percent of cases with clear margins
Percent of cases requiring a second operation [ Time Frame: Upon completion of pathologic assessment-which will occur within 24-48 hours after surgery ] [ Designated as safety issue: No ]
How often patients are not required to have repeat procedures

Contact

Steven Shivers
University of South Florida- Florida Hospital Tampa
3100 East Fletcher Avenue
Tampa, FL 33613
Phone: 813-974-3042

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