An interventional study of SAVI SCOUT Surgical Guidance System in Breast Diseases, sponsored by Envision Healthcare Scientific Intelligence, Inc.. Completed at 1 site in United States. Open to female participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-05-11.
Sponsored by Envision Healthcare Scientific Intelligence, Inc. · Not applicable, Interventional, and Health services research
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.
The SAVI SCOUT (Cianna Medical, Inc.) surgical guidance system received 510(k) U.S. Food and Drug Administration (FDA) approval in August 2014. This system is used as a standard of care since 2015 in the Memorial Healthcare System (MHS) operating rooms by experienced breast surgeons (over 150 MHS breast cancer patients and over 5,000 U.S. breast cancer patients as of September 2016). In MHS standard of care practice, the device is placed at the target lesion(s) under image-guidance by the radiologist up to 30 days prior to surgery.
Patients with certain types of breast cancer undergo neoadjuvant treatment with biologic (hormonal) and/or chemotherapy with the goal of decreasing the tumor volume prior to definitive surgery. If the original cancer lesion(s) resolve completely, this is called complete pathologic response (pCR). pCR and even a partial response, while good for the patient, can result in disappearance or poor visualization of the target and often render pre-operative image-guided localization by the radiologist more difficult and less reliable. This can result in unintended larger, more disfiguring breast cancer surgery. Therefore, if the SCOUT device can be placed prior to treatment response, when the lesion is clearly visualized on imaging, accurate image-guided targeting is optimal and thus placement and subsequent surgery should be more accurate. If this pilot study demonstrates successful performance of the device without device-related complications, it will bring improved value to future patients who will require fewer and/or less extensive pre-operative and surgical procedures. Some value may also be provided to subjects as the targeting before tumor shrinkage is expected to be more accurate.
Thus, this pilot study will assess the performance of FDA-cleared SCOUT system over a longer duration prior to breast and/or axillary lymph node surgery.
153 studies on the registry are indexed under Breast Diseases; 25 are open to participants now.
This study's enrollment of 34 is below the median of 120 across 95 interventional studies indexed under Breast Diseases.
Browse Breast Diseases studies →Envision Healthcare Scientific Intelligence, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
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.
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.
Time frame: 31 - 365 days prior to surgery
| Milestone | SCOUT Device |
|---|---|
| Started | 34 |
| Completed | 34 |
| Not completed | 0 |
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.
| Participants | SCOUT Device |
|---|---|
| Number of Participants Considered to Have a Successful Surgery | 34 |
Collected over 0 months - 14 months. Reportable adverse events were collected from the time after informed consent is obtained until 30 days (for non-serious AEs) or 7 days (for SAEs) after the last day of study participation. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SCOUT Device | 0/34 (0%) | 0/34 (0%) | 0/34 (0%) |
| Age, Continuous(years) | SCOUT Device |
|---|---|
| Mean | 50 (28 to 74) |
| Sex: Female, Male(Participants) | SCOUT Device |
|---|---|
| Female | 34 |
| Male | 0 |
| Race/Ethnicity, Customized(Participants) | SCOUT Device |
|---|---|
| Caucasian | 10 |
| African American | 12 |
| Hispanic | 11 |
| Other | 1 |
| Node Positive(Participants) | SCOUT Device |
|---|---|
| Count of participants | 23 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Feb 2017 to primary completion in Sep 2018, 19 months.
Results were first posted in May 2020, 1 year 8 months after primary completion.
Of 29 interventional studies with no phase under Breast Diseases, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 65. This study's 19 months is below that.
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This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Envision Healthcare Scientific Intelligence, Inc.