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
About this trial
This is an interventional treatment trial for Breast Neoplasm focused on measuring lumpectomy, breast conserving surgery
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:
-
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
NCT ID
NCT02370082
First Posted
February 2, 2015
Last Updated
March 5, 2015
Sponsor
Cianna Medical, Inc.
Collaborators
University of South Florida
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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