Breast NeoplasmNCT02370082
SAVI SCOUT Clinical Evaluation Study
A study testing Localization of breast lesion in people with Breast Neoplasm, run by Cianna Medical, Inc..
Trial summary
The purpose of this study is to evaluate the performance of the SAVI SCOUT® Surgical Guidance System (SAVI SCOUT). The SAVI SCOUT is a medical device, used to provide real-time guidance during localized excisional biopsy or lumpectomy procedures, by helping the surgeon locate and remove the desired tissue (i.e., the… Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- Localization of breast lesion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Patient has a non-palpable breast lesion that requires excision
- Lesion depth ≤ 3 cm from the skin surface in the supine position
- Patient is scheduled for excision or BCT at a participating institution
- Patient is between the ages of 18 and 90 years
- Patient is female
- Patient is willing and able to comply with all study procedures and be available to follow-up for the duration of the study
Show all 13Show fewer
- For lesions requiring multiple reflectors for localization, they must allow for reflectors to be placed ≥ 1cm from one another relative to the coronal plane Subject Exclusion Criteria
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Patient had a previous ipsilateral breast cancer
- Patient has multicentric breast cancer
- Patient has Stage IV breast cancer
- Patient has been treated with neoadjuvant chemotherapy
- Patient is pregnant or lactating
Who cannot join
- -
About this study
Official title: A Prospective, Single-Arm, Multi-Site, Clinical Evaluation of the SAVI SCOUT® Surgical Guidance System for the Location of Non-Palpable Breast Lesions During Excision
The purpose of this study is to evaluate the performance of the SAVI SCOUT® Surgical Guidance System (SAVI SCOUT). The SAVI SCOUT is a medical device, used to provide real-time guidance during localized excisional biopsy or lumpectomy procedures, by helping the surgeon locate and remove the desired tissue (i.e., the lesion and surrounding normal tissue). The SAVI SCOUT has been 510K cleared.
The SAVI SCOUT is intended to assist surgeons in the location and retrieval of a non-palpable abnormality as localized by radiographic or ultrasound methods. In this study, the ability of the SAVI SCOUT to guide surgeons to find a lesion will be evaluated instead of the standard technique of wire localization.
Read the detailed description
Using radiography or ultrasound guidance, the SAVI SCOUT reflector will be placed percutaneously up to 7 days prior to the scheduled excisional procedure. During surgical excision, the SAVI SCOUT system will be used to locate the reflector, which will be removed along with the surrounding breast tissue.
Final data analysis will be completed within 1 month after the last patient is treated.
Final assessment of the surgical results will be completed by the surgeon during a routine follow-up visit within 1 month following the surgical excision or lumpectomy procedure.
Main Objective: to show that the SAVI SCOUT technique can be used to safely and effectively locate a non-palpable breast lesion during a localized excisional biopsy or lumpectomy procedure.
Up to 10 sites and 150 patients will be enrolled.
- Conditions
- Breast Neoplasm
- Being tested
- Localization of breast lesion
- Keywords
- lumpectomy, breast conserving surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Localization of breast lesionDevice
localization of breast lesion for removal
| Study group | Role | What they receive |
|---|---|---|
| SAVI SCOUT device | Experimental | SAVI SCOUT device used to localize breast lesion which will then be removed surgically. The SAVI SCOUT is the intervention for localization of breast lesions. Receives: Device: Localization of breast lesion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of reflector placement
How often the reflector can be successfully placed
Measured: intraoperative
Secondary outcomes (2)
Amount of tissue excised
Pathologic assessment of how much tissue was removed
Measured: Will be assessed by pathologist during standard pathology assessment which occurs 24-48 hours after surgery
Percent of cases with clear margins • Percent of cases requiring a second operation
How often patients are not required to have repeat procedures
Measured: Upon completion of pathologic assessment-which will occur within 24-48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cianna Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of South Florida
- Responsible party
- Sponsor
- Investigators
- Charles Cox, MD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02370082
- Sponsor's protocol ID
- Pro00019820
- Status last verified
- Feb 2015
- First submitted
- 2 Feb 2015
- Last updated
- 9 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm, Multi-Site, Clinical Evaluation of the SAVI SCOUT® Surgical Guidance System for the Location of Non-Palpable Breast Lesions During Excision
- ClinicalTrials.gov ID
- NCT02370082
- Acronym / sponsor ID
- Pro00019820
- Conditions
- Breast Neoplasm
- Keywords
- lumpectomy, breast conserving surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Cianna Medical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of South Florida
- Study start
- Feb 2015
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 24 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the performance of the SAVI SCOUT® Surgical Guidance System (SAVI SCOUT). The SAVI SCOUT is a medical device, used to provide real-time guidance during localized excisional biopsy or lumpectomy procedures, by helping the surgeon locate and remove the desired tissue (i.e., the lesion and surrounding normal tissue). The SAVI SCOUT has been 510K cleared.
The SAVI SCOUT is intended to assist surgeons in the location and retrieval of a non-palpable abnormality as localized by radiographic or ultrasound methods. In this study, the ability of the SAVI SCOUT to guide surgeons to find a lesion will be evaluated instead of the standard technique of wire localization.
Detailed description
Using radiography or ultrasound guidance, the SAVI SCOUT reflector will be placed percutaneously up to 7 days prior to the scheduled excisional procedure. During surgical excision, the SAVI SCOUT system will be used to locate the reflector, which will be removed along with the surrounding breast tissue.
Final data analysis will be completed within 1 month after the last patient is treated.
Final assessment of the surgical results will be completed by the surgeon during a routine follow-up visit within 1 month following the surgical excision or lumpectomy procedure.
Main Objective: to show that the SAVI SCOUT technique can be used to safely and effectively locate a non-palpable breast lesion during a localized excisional biopsy or lumpectomy procedure.
Up to 10 sites and 150 patients will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SAVI SCOUT device | Experimental | Device: Localization of breast lesionSAVI SCOUT device used to localize breast lesion which will then be removed surgically. The SAVI SCOUT is the intervention for localization of breast lesions. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- • Patient has a non-palpable breast lesion that requires excision
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Patient had a previous ipsilateral breast cancer
- Patient has multicentric breast cancer
- Patient has Stage IV breast cancer
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Localization of breast lesionlocalization of breast lesion for removal | Device | SAVI SCOUT device |
Primary outcome
Success rate of reflector placement
Time frame: intraoperative
How often the reflector can be successfully placed
2 secondary outcomes
Amount of tissue excised
Time frame: Will be assessed by pathologist during standard pathology assessment which occurs 24-48 hours after surgery
Percent of cases with clear margins • Percent of cases requiring a second operation
Time frame: Upon completion of pathologic assessment-which will occur within 24-48 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2015.
Related trials for Breast Neoplasm
Active, not recruitingObservational study
Assessment of Cognitive Function in Breast Cancer and Lymphoma Patients Receiving Chemotherapy
Breast Cancer, Lymphoma
RecruitingObservational study
National Mammography Database
Breast Cancer Screening and Diagnosis
Active, not recruiting
Node Negative, Invasive Breast Cancer Single Fraction IOERT
Breast Cancer
RecruitingPhase 2
Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis
Metastatic Breast Cancer, Leptomeningeal Disease
Active, not recruitingPhase 1/2
Accelerated Radiation Therapy (ART) to the Breast and Nodal Stations
Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Cox, MD principal investigator
University of South Florida
Questions about this trial
What is this clinical trial studying?
A study testing Localization of breast lesion in people with Breast Neoplasm, run by Cianna Medical, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of reflector placement (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2015; AzTrials last refreshed its copy on 28 Oct 2026.