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SAVI SCOUT Clinical Evaluation Study

Primary Purpose

Breast Neoplasm

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Localization of breast lesion
Sponsored by
Cianna Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasm focused on measuring lumpectomy, breast conserving surgery

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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:

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    SAVI SCOUT device

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Success rate of reflector placement
    How often the reflector can be successfully placed

    Secondary Outcome Measures

    Amount of tissue excised
    Pathologic assessment of how much tissue was removed
    Percent of cases with clear margins • Percent of cases requiring a second operation
    How often patients are not required to have repeat procedures

    Full Information

    First Posted
    February 2, 2015
    Last Updated
    March 5, 2015
    Sponsor
    Cianna Medical, Inc.
    Collaborators
    University of South Florida
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02370082
    Brief Title
    SAVI SCOUT Clinical Evaluation Study
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2015 (undefined)
    Primary Completion Date
    August 2015 (Anticipated)
    Study Completion Date
    August 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Cianna Medical, Inc.
    Collaborators
    University of South Florida

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Neoplasm
    Keywords
    lumpectomy, breast conserving surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SAVI SCOUT device
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Localization of breast lesion
    Intervention Description
    localization of breast lesion for removal
    Primary Outcome Measure Information:
    Title
    Success rate of reflector placement
    Description
    How often the reflector can be successfully placed
    Time Frame
    intraoperative
    Secondary Outcome Measure Information:
    Title
    Amount of tissue excised
    Description
    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
    Title
    Percent of cases with clear margins • Percent of cases requiring a second operation
    Description
    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

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    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 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: -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Charles Cox, MD
    Organizational Affiliation
    University of South Florida
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    SAVI SCOUT Clinical Evaluation Study

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