Trials / Completed
CompletedNCT04604561
Evaluation of EnVisio SmartClip for Intraoperative Localization of Breast Masses
Physician Initiated Evaluation of EnVisio SmartClip for Intraoperative Localization of Breast Masses
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 50 (actual)
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | EnVisio SmartClip | The Envisio SmartClip is an FDA-cleared (approved) device for localization of in-breast lesions. While using The EnVisio™ Navigation System, the system will detect the presence of the SmartClip™ Soft Tissue Marker(s) and provide real-time three-dimensional navigation during the surgery. |
| DEVICE | EnVisio™ Navigation System | The EnVisio™ Navigation System acquires and analyzes electromagnetic signatures that display the relative distance, depth, and direction from the tip of the electrosurgical tool to the implanted SmartClipTM(s) within the surgeon's field of view during the procedure. |
Timeline
- Start date
- 2020-10-27
- Primary completion
- 2023-07-26
- Completion
- 2023-07-26
- First posted
- 2020-10-27
- Last updated
- 2026-04-01
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04604561. Inclusion in this directory is not an endorsement.