Long Term Use of SAVI SCOUT: Pilot Study

NCT03015649 | Completed Results FDA Device

• 1 other identifier: CMI-SCOUT-001
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Diseases

Keywords

breast cancer; neoadjuvant treatment; surgical guidance system

Outcome Measures

Primary Outcomes (1)

• Number of Participants Considered to Have a Successful Surgery

  The primary endpoint of this study is successful surgery. Successful surgery (defined as one where the device stays in place and can be removed successfully during surgery) when this device is placed 31 - 365 days prior to surgery. Unsuccessful surgery is defined as one where the device does not stay in place and/or cannot be removed successfully during surgery) when this device is placed 31 - 365 days prior to surgery.

  31 - 365 days prior to surgery

Study Arms (1)

SCOUT device

EXPERIMENTAL

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.

Device: SAVI SCOUT Surgical Guidance System

Interventions

SAVI SCOUT Surgical Guidance System 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.

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Envision Healthcare Scientific Intelligence, Inc.: lead
• Cianna Medical, Inc.: collaborator

Study Sites (1)

Envision Physician Scientific Research, Inc. formerly Sheridan Healthcare, Inc.

Plantation, Florida, 33322, United States

Location

Related Publications (4)

• Cox CE, Garcia-Henriquez N, Glancy MJ, Whitworth P, Cox JM, Themar-Geck M, Prati R, Jung M, Russell S, Appleton K, King J, Shivers SC. Pilot Study of a New Nonradioactive Surgical Guidance Technology for Locating Nonpalpable Breast Lesions. Ann Surg Oncol. 2016 Jun;23(6):1824-30. doi: 10.1245/s10434-015-5079-x. Epub 2016 Feb 3.

  PMID: 26847680 BACKGROUND

• Caudle AS, Yang WT, Mittendorf EA, Black DM, Hwang R, Hobbs B, Hunt KK, Krishnamurthy S, Kuerer HM. Selective surgical localization of axillary lymph nodes containing metastases in patients with breast cancer: a prospective feasibility trial. JAMA Surg. 2015 Feb;150(2):137-43. doi: 10.1001/jamasurg.2014.1086.

  PMID: 25517573 BACKGROUND

• Hylton NM, Gatsonis CA, Rosen MA, Lehman CD, Newitt DC, Partridge SC, Bernreuter WK, Pisano ED, Morris EA, Weatherall PT, Polin SM, Newstead GM, Marques HS, Esserman LJ, Schnall MD; ACRIN 6657 Trial Team and I-SPY 1 TRIAL Investigators. Neoadjuvant Chemotherapy for Breast Cancer: Functional Tumor Volume by MR Imaging Predicts Recurrence-free Survival-Results from the ACRIN 6657/CALGB 150007 I-SPY 1 TRIAL. Radiology. 2016 Apr;279(1):44-55. doi: 10.1148/radiol.2015150013. Epub 2015 Dec 1.

  PMID: 26624971 BACKGROUND

• Mango V, Ha R, Gomberawalla A, Wynn R, Feldman S. Evaluation of the SAVI SCOUT Surgical Guidance System for Localization and Excision of Nonpalpable Breast Lesions: A Feasibility Study. AJR Am J Roentgenol. 2016 Oct;207(4):W69-W72. doi: 10.2214/AJR.15.15962. Epub 2016 Jun 15.

  PMID: 27304083 BACKGROUND

MeSH Terms

Conditions

Breast Diseases; Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Principal Investigator has left the organization.

Results Point of Contact

• Title: Women's Imaging Director
• Organization: Envision Healthcare Scientific Intelligence, Inc.

clinicaltrials@shcr.com

9549397729

Study Officials

• Mary Hayes-Macaluso, MD

  Envision Healthcare Scientific Intelligence, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2017
• First Posted: January 10, 2017
• Study Start: February 3, 2017
• Primary Completion: September 10, 2018
• Study Completion: April 4, 2019
• Last Updated: May 11, 2020
• Results First Posted: May 11, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)