N/A
Completed N=34
Long Term Use of SAVI SCOUT: Pilot Study
Breast Diseases
Source: ClinicalTrials.gov NCT03015649 ↗
Enrolled (actual)
34
Serious AEs
0.0%
Results posted
May 2020
Primary outcomePrimary: Number of Participants Considered to Have a Successful Surgery — 34 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Considered to Have a Successful Surgery |
34 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03015649). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.