Single Step Lesion Annotation and Localization of Suspicious Breast Lesions
Public ClinicalTrials.gov record NCT05118295. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The SAVI Reflector is a nonradioactive infrared (IR)-activated electromagnetic wave device that can be implanted in the breast or lymph nodes under image-directed guidance, typically by mammography or sonography. Intraoperatively, the SCOUT hand-held device is then percutaneously applied to the breast or lymph node, creating an audible signal on the device console with a gradient which correlates to distance (in mm) from the target lesion and marker. The Savi Scout surgical guidance system was approved by the U.S. Food and Drug Administration in 2014. Furthermore, it was approved for long term use, with no restrictions on the length of time in 2017. The system consists of an implantable reflector with a 4-mm body size, preloaded in a 16-gauge deliverable needle, a hand-held probe and a console. The reflector consists of an IR light receptor, resistor switch and two antennae. This is placed into or near the target through a 16G needle under mammographic or sonographic guidance. The hand-held probe detects pulses of infrared (IR) light and radar wave signals, received by the console system, which then emits and receives signals back to the reflector to provide real time localization and target proximity information to the surgeon. The SCOUT console provides audible and visual feedback intraoperatively, the frequency of which increases as the handheld reader approaches the implanted reflector. After excision of the breast lesion, the handheld reader can be used to immediately confirm removal of the reflector, present in the lumpectomy specimen, and subsequent quiescence of radar signal in the breast.
Study identification
- NCT ID
- NCT05118295
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Early Phase 1
- Enrollment
- 27 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 10, 2022
- Primary completion
- Jan 21, 2025
- Completion
- Jan 21, 2025
- Last update posted
- Jan 26, 2025
2022 – 2025
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05118295, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 26, 2025 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05118295 live on ClinicalTrials.gov.