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SAVI SCOUT Clinical Evaluation Study

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ClinicalTrials.gov Identifier: NCT02370082
Recruitment Status : Unknown
Verified February 2015 by Cianna Medical, Inc..
Recruitment status was:  Enrolling by invitation
First Posted : February 24, 2015
Last Update Posted : March 9, 2015
Sponsor:
Collaborator:
University of South Florida
Information provided by (Responsible Party):
Cianna Medical, Inc.

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.


Condition or disease Intervention/treatment Phase
Breast Neoplasm Device: Localization of breast lesion Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2015
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Device: Localization of breast lesion
localization of breast lesion for removal




Primary Outcome Measures :
  1. Success rate of reflector placement [ Time Frame: intraoperative ]
    How often the reflector can be successfully placed


Secondary Outcome Measures :
  1. Amount of tissue excised [ Time Frame: Will be assessed by pathologist during standard pathology assessment which occurs 24-48 hours after surgery ]
    Pathologic assessment of how much tissue was removed

  2. 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 ]
    How often patients are not required to have repeat procedures



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02370082


Sponsors and Collaborators
Cianna Medical, Inc.
University of South Florida
Investigators
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Principal Investigator: Charles Cox, MD University of South Florida
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Responsible Party: Cianna Medical, Inc.
ClinicalTrials.gov Identifier: NCT02370082    
Other Study ID Numbers: Pro00019820
First Posted: February 24, 2015    Key Record Dates
Last Update Posted: March 9, 2015
Last Verified: February 2015
Keywords provided by Cianna Medical, Inc.:
lumpectomy
breast conserving surgery
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases