Clinical trial · Observational
Prospective Analysis of EnVisio Spatial Intelligence for Soft Tissue Localization and Guided Surgical Excision
NCT06572410CI-TRIAL-00080191unknownClinicalTrials.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)
Observational study. The purpose of this study is to evaluate the use of real-time surgical navigation for the localization and surgical removal of soft tissue tumors. The goal is to collect information about the efficiency and effectiveness of the EnVisio Surgical Navigation for intraoperative guidance to obtain negative margin on initial specimen. Prospective Patient Study: 200 consecutive patients
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 |
|---|---|---|---|
| Tumors, Breast | Breast Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EnVisio Navigation System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Cohort 1
- description
- Patient has selected breast conservation therapy
- interventionNames
- Device: EnVisio Navigation System
Primary outcomes (1)
- measure
- Margin Positivity
- timeFrame
- Day of Surgery
- description
- Specimen surgical resection volume gross measurements in 3 dimensions (length, width, depth) day of surgery. Definitive gross pathology results on final margin
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient has image identifiable lesion. * Patient has selected breast conservation therapy IE: lumpectomy +/-radiation therapy, +/- chemotherapy +/- hormonal or targeted therapies. Neoadjuvant chemotherapy is not an exclusion criterion. * Patient will be undergoing target tissue localization with the SmartClip * Patient will be undergoing BCS Breast Conserving Surgery treatment for DCIS or invasive breast cancer with EnVisio ® Navigation System. * Patient must be age \> or = 18 years. * Patients unable to provide consent to surgery must have authorized representative provide consent. Exclusion Criteria: * Patients undergoing mastectomy for resection of the targeted lesion. * Patient is localized with an alternative method. * Patient that are pregnant.
References
Publications (0)
Data not yet available
No reference posted for this study.