CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 34 enrolled
Drug / intervention
SAVI SCOUT Surgical Guidance Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03015649
NCT03015649N/ACompleted

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

Envision Healthcare Scientific Intelligence, Inc.·interventional·Posted Jan 10, 2017·Updated May 11, 2020

In Brief

A clinical study evaluating SAVI SCOUT Surgical Guidance System for Breast Diseases. Completed, enrolled 34 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Diseases
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJan 10, 2017
Enrollment StartFeb 3, 2017
Primary CompletionSep 10, 2018
Study CompletionApr 4, 2019
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 9.5 years ago

Interventions

SAVI SCOUT Surgical Guidance Systemdevice

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.