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NCT04604561 · ClinicalTrials.gov registry record
Evaluation of EnVisio SmartClip for Intraoperative Localization of Breast Masses
A clinical trial, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- 50
- Enrollment target
NCT04604561: Completed study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT04604561 is a clinical trial that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 50 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04604561 has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- 50 participants
- Enrollment target
Study 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.
Primary Outcome
Questions 1,2,5,6,7 \& 8 from the Radiologist survey will evaluate the EnVisio system for reproducible in-breast tumor localization by the performing physicians.
Interventions
- DEVICE EnVisio SmartClip
- DEVICE EnVisio™ Navigation System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2020-10-27 |
| Est. Completion | 2023-07-26 |
What the finished NCT04604561 record still lists
NCT04604561 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which EnVisio SmartClip is the first listed.
NCT04604561 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04604561 about?
NCT04604561 is a clinical study titled "Evaluation of EnVisio SmartClip for Intraoperative Localization of Breast Masses". 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.
What is the current status of trial NCT04604561?
This trial is currently completed. The enrollment target is 50 participants. The study started on 2020-10-27. Estimated completion is 2023-07-26.
What interventions are being tested in trial NCT04604561?
The interventions under investigation include: EnVisio SmartClip (DEVICE), EnVisio™ Navigation System (DEVICE).
Who is sponsoring clinical trial NCT04604561?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
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