Using EnVisio Navigation for Breast Tumor Surgery
Prospective Analysis of EnVisio Spatial Intelligence for Soft Tissue Localization and Guided Surgical Excision
Elucent Medical · NCT06572410
This study is testing if a new navigation system can help surgeons remove breast tumors more accurately and improve outcomes for patients undergoing breast-conserving surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Elucent Medical (industry) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Winter Garden, Florida) |
| Trial ID | NCT06572410 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of the EnVisio Surgical Navigation System in guiding the surgical removal of soft tissue tumors in the breast. It will collect data on localization accuracy, negative margins on specimens, and overall surgical efficiency during procedures involving image identifiable lesions. The study will involve 200 consecutive patients undergoing breast-conserving surgery, with data collected on various clinical outcomes and procedural metrics. The goal is to improve surgical precision and patient outcomes in breast cancer treatment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with image identifiable breast lesions who are planning to undergo breast-conserving surgery.
Not a fit: Patients undergoing mastectomy or those with lesions localized by alternative methods may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more precise tumor removals and better surgical outcomes for breast cancer patients.
How similar studies have performed: Other studies utilizing advanced surgical navigation systems have shown promising results, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Winter Garden, Florida
- Advent Winter Garden — Winter Garden, Florida, United States (RECRUITING)
Study contacts
- Study coordinator: Jason A Boardman, MD
- Email: jaboardmanmd@hotmail.com
- Phone: 352-243-2622
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Tumors, Breast