Clinical trial · Observational
Evaluation of EnVisio SmartClip for Intraoperative Localization of Breast Masses
Physician Initiated Evaluation of EnVisio SmartClip for Intraoperative Localization of Breast Masses
NCT04604561CI-TRIAL-00106967completedClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a pilot study to estimate the success of the SmartClip device for accurate placement and reproducibility of intraoperative identification of in-breast lesions and for excision utilizing surgical navigation indicators.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EnVisio SmartClip | Device | — | UNRESOLVED |
| EnVisio™ Navigation System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Participants receiving SmartClip
- description
- Participants will undergo a preoperative physical exam and at least one preoperative ultrasound demonstrating the mass for resection. The SmartClip will be placed under ultrasound guidance. Post-placement mammogram will be obtained after placement of the clip. The SmartClip can be placed up to 30 days prior to the planned surgical resection. At the time of definitive surgery, the Envisio system will be used to identify the clip and the targeted lesion for resection. Intraoperatively, a specimen radiograph will be performed to confirm the presence of the SmartClip and the targeted lesion in the surgical specimen. The breast surgical specimen will be sent for gross examination, including measurements of the tumor in 3 axes. Immediately post-procedure, the performing surgeon will fill out a questionnaire to determine the ability of localizing in-breast lesions using the Envisio Navigation and SmartClip system in surgery.
- interventionNames
- Device: EnVisio SmartClip
- Device: EnVisio™ Navigation System
- label
- Radiologist Placing SmartClip
- description
- Radiologist will place SmartClip under ultrasound guidance. A Post-placement mammogram will be obtained after placement of the SmartClip. Immediately post-procedure, the performing radiologist will fill out a questionnaire.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants must have at least one and up to 3 sonographically or mammographically identifiable in-breast or axillary targets and consent to undergo a surgical resection using the SmartClip localization system at the McKinley operative suites at Moffitt Cancer Center. Multiple sites for localization may be used, up to a maximum of 3 SmartClips per patient. Mammographically or sonographically visible biopsy clips may be used as a localizing target. * Participants must be age \> or = 18 years. Exclusion Criteria: * Participants with sonographically or mammographically occult target lesions * Participants with greater than 35cm chest to bust depth * Participants undergoing mastectomy for resection of the targeted lesion * Inability to undergo surgery at the McKinley OR suites due to institutional anesthesia guidelines * Patients requiring use of more than 3 SmartClips to localize targets
References
Publications (0)
Data not yet available
No reference posted for this study.