Long Term Use of SAVI SCOUT: Pilot Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-03

Study Completion Date

2019-04-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Breast Margin Study: Routine Cavity Shave Margins Vs. Selective Margins Using Savi Scout®

NCT05825482

Breast Cancer

RECRUITING NA

Robot Assisted Mastectomy Via Axillary Way With Areola Conservation and Immediate Reconstruction

NCT02673268

Breast Cancer

UNKNOWN PHASE2

Spot tm Tattooing of Biopsied Axillary Lymph Nodes With Ultrasound Guided in Breast Cancer Patients Prior to Surgery

NCT02617264

Breast Cancer

UNKNOWN NA

SABER Study for Selected Early Stage Breast Cancer

NCT04360330

Breast Cancer Early-stage Breast Cancer

RECRUITING NA

Sienna+® Injection Time Study 4 Arms

NCT02612870

Breast Neoplasms

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SCOUT device

The study population consists of 25 - 35 adult surgical patient volunteers who plan to have definitive breast cancer surgery at Memorial Healthcare System (MHS) Hospitals after neoadjuvant treatment.

The investigator will identify subjects who meet inclusion/exclusion criteria, obtain patient's consent and schedule the subject for the SAVI SCOUT Surgical Guidance System procedure. All study participants will receive the same treatment assignment, i.e. lesion localization with the SCOUT device 31 - 365 days prior to surgery. Neoadjuvant treatment decisions will be determined by patient's medical oncologist.

Group Type EXPERIMENTAL

SAVI SCOUT Surgical Guidance System

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patient is willing and able to provide informed consent. Patient SCOUT device(s) is placed as part of routine care or study but before neoadjuvant treatment begins.
* Patient is female.
* Patient is between the ages of 18 and 90 years.
* Patient has breast cancer and will undergo neoadjuvant therapy and excision at Memorial Healthcare System.
* Patient is willing and able to comply with all study procedures and be available to follow-up for the duration of the study (1 - 13 months).
* Patient reads or understands English or Spanish.

Exclusion Criteria

* Patient is pregnant.
* Patient has pacemaker or implantable defibrillators (These have not been bench tested as of September 2016).
* Patient has known or suspected nickel allergy.
* Patient is scheduled or receiving investigational drugs for neoadjuvant regimen. (This could confound UADE of this device.)
* Patient has any condition that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
* Patient has other malignancy except for adequately treated and cured basal or squamous cancer, curatively treated in situ disease or any other cancer for which the patient has been disease free for greater than or equal to 5 years.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No