SAVI SCOUT Clinical Evaluation Study

NCT02370082 | Unknown

• 1 other identifier: Pro00019820
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Neoplasm

Keywords

lumpectomy; breast conserving surgery

Outcome Measures

Primary Outcomes (1)

• Success rate of reflector placement

  How often the reflector can be successfully placed

  intraoperative

Secondary Outcomes (2)

• Amount of tissue excised

  Will be assessed by pathologist during standard pathology assessment which occurs 24-48 hours after surgery

• Percent of cases with clear margins • Percent of cases requiring a second operation

  Upon completion of pathologic assessment-which will occur within 24-48 hours after surgery

Study Arms (1)

SAVI SCOUT device

EXPERIMENTAL

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

Interventions

Localization of breast lesion DEVICE

localization of breast lesion for removal

SAVI SCOUT device

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cianna Medical, Inc.: lead
• University of South Florida: collaborator

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Charles Cox, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2015
• First Posted: February 24, 2015
• Study Start: February 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: March 9, 2015

Record last verified: 2015-02