NCT03015649

Long Term Use of SAVI SCOUT: Pilot Study

Evaluation of Longer Duration Use of the SAVI SCOUT Surgical Guidance System for Excision of Breast and Axillary Lesions in Neo-adjuvant Therapy Patients: A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Envision Healthcare Scientific Intelligence, Inc. · Academic / Other
• Sex: Female
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the performance of FDA-cleared SAVI SCOUT Breast Localization and Surgical Guidance System (SCOUT) over a longer duration prior to surgery. The device is a non-wire system, which uses nonradioactive light-activated radar, to provide breast surgeons with real-time guidance to locate and remove the target lesion in the breast and/or axillary tissue. The SCOUT device standard of care use is placement up to 30 days prior to surgery to assist surgeons in the localization and retrieval of breast/axillary lesions. Routine image-guided methods (Mammography, Ultrasound, and CT) are used. In this study, investigators will assess the longer term placement of the SCOUT device over an extended time (31 - 365 days) in order to address the needs of patients who require neoadjuvant treatment prior to definitive surgery.

Detailed description

The SAVI SCOUT (Cianna Medical, Inc.) surgical guidance system received 510(k) U.S. Food and Drug Administration (FDA) approval in August 2014. This system is used as a standard of care since 2015 in the Memorial Healthcare System (MHS) operating rooms by experienced breast surgeons (over 150 MHS breast cancer patients and over 5,000 U.S. breast cancer patients as of September 2016). In MHS standard of care practice, the device is placed at the target lesion(s) under image-guidance by the radiologist up to 30 days prior to surgery. Patients with certain types of breast cancer undergo neoadjuvant treatment with biologic (hormonal) and/or chemotherapy with the goal of decreasing the tumor volume prior to definitive surgery. If the original cancer lesion(s) resolve completely, this is called complete pathologic response (pCR). pCR and even a partial response, while good for the patient, can result in disappearance or poor visualization of the target and often render pre-operative image-guided localization by the radiologist more difficult and less reliable. This can result in unintended larger, more disfiguring breast cancer surgery. Therefore, if the SCOUT device can be placed prior to treatment response, when the lesion is clearly visualized on imaging, accurate image-guided targeting is optimal and thus placement and subsequent surgery should be more accurate. If this pilot study demonstrates successful performance of the device without device-related complications, it will bring improved value to future patients who will require fewer and/or less extensive pre-operative and surgical procedures. Some value may also be provided to subjects as the targeting before tumor shrinkage is expected to be more accurate. Thus, this pilot study will assess the performance of FDA-cleared SCOUT system over a longer duration prior to breast and/or axillary lymph node surgery.

Conditions

• Breast Diseases

Interventions

Type	Name	Description
DEVICE	SAVI SCOUT Surgical Guidance System	SAVI SCOUT Surgical Guidance System is a non-wire system, which uses nonradioactive light-activated radar, to provide breast surgeons with real-time guidance to locate and remove the target lesion in the breast and/or axillary tissue.

Timeline

• Start date: 2017-02-03
• Primary completion: 2018-09-10
• Completion: 2019-04-04
• First posted: 2017-01-10
• Last updated: 2020-05-11
• Results posted: 2020-05-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study