Clinical trial · Interventional
Evaluation and Outcomes of SAVI Scout MD for Localized Breast Surgery
Clinical Evaluation and Outcomes of Multi-signal SAVI Scout (Scout MD) Localized Breast Conserving Surgery
NCT07686250CI-TRIAL-00119907recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Summary
Brief summary (as posted)
The purpose of the study is to evaluate how precise the SAVI Scout MD is and how easy it is for surgeons to use during surgery. The SAVI Scout MD system uses tiny radar reflectors instead of wires, can be placed days or weeks before surgery, helps surgeons find the cancer more precisely and may lower the chance of needing a second surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SAVI Scout MD system | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SAVI Scout MD Localization
- description
- Participants undergo image-guided placement of multiple Scout MD reflectors followed by breast-conserving surgery using the device for intraoperative localization.
- interventionNames
- Device: SAVI Scout MD system
Primary outcomes (1)
- measure
- Successful Operation Rate (SOR)
- timeFrame
- Up to 6 weeks.
- description
- Proportion of patients achieving complete tumor resection with negative surgical margins ("no tumor on ink" or ≥2 mm for DCIS).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult females who are 18 years of age or older at time of signing informed consent will be eligible. * Must have ability to comprehend and the willingness to sign written informed consent for study participation. * Patients must have at least one sonographically, mammographically, or MRI identifiable in-breast malignancy and consent to undergo a surgical resection requiring bracketed localization (more than one localizing marker) at Moffitt Cancer Center. Mammographically or sonographically visible biopsy clips may be used as a localizing target. Exclusion Criteria: * Patients undergoing mastectomy for resection of the targeted lesion. * Planned excision of multiple separate sites in the ipsilateral breast. * Inability to undergo surgery at Moffitt Cancer Center.
References
Publications (0)
Data not yet available
No reference posted for this study.