Clinical trial · Interventional
SAVI SCOUT Clinical Evaluation Study
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
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 Neoplasm | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Localization of breast lesion | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SAVI SCOUT device
- description
- 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.
- interventionNames
- Device: Localization of breast lesion
Primary outcomes (1)
- measure
- Success rate of reflector placement
- timeFrame
- intraoperative
- description
- How often the reflector can be successfully placed
Secondary outcomes (2)
- measure
- Amount of tissue excised
- timeFrame
- Will be assessed by pathologist during standard pathology assessment which occurs 24-48 hours after surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * • 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 * 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 Exclusion Criteria: \-
References
Publications (0)
Data not yet available