MedTrace Logo

Long Term Use of SAVI SCOUT: Pilot Study

NCT03015649 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2020-05-11

Study results available
· View outcomes & findings →

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

Interventions

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.

Sponsors & Collaborators

  • Cianna Medical, Inc.

    collaborator INDUSTRY

  • Envision Healthcare Scientific Intelligence, Inc.

    lead OTHER

Principal Investigators

  • Mary Hayes-Macaluso, MD · Envision Healthcare Scientific Intelligence, Inc.

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-03
Primary Completion
2018-09-10
Completion
2019-04-04
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03015649 on ClinicalTrials.gov