Breast CancerNCT04604561
Evaluation of EnVisio SmartClip for Intraoperative Localization of Breast Masses
An observational study of Breast Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- EnVisio SmartClip and EnVisio™ Navigation System
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2020to 26 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited to this study from the Moffitt Cancer Center Comprehensive Breast Clinic. Patients are seen in this clinic by breast surgeons from the Comprehensive Breast Program at Moffitt Cancer Center.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physician Initiated 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.
- Conditions
- Breast Cancer
- Being tested
- EnVisio SmartClip, EnVisio™ Navigation System
- Keywords
- SmartClip, EnVisio™ Navigation System
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnVisio SmartClipDevice
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.
EnVisio™ Navigation SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving SmartClip | 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. Receives: Device: EnVisio SmartClip; Device: EnVisio™ Navigation System | |
| Radiologist Placing SmartClip | 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. Receives: Device: EnVisio SmartClip; Device: EnVisio™ Navigation System | |
| Surgeon | The surgeon will use the EnVisio™ Navigation System to identify the SmartClip and the targeted lesion for resection. Immediately post-procedure, the performing surgeon will fill out a questionnaire Receives: Device: EnVisio SmartClip; Device: EnVisio™ Navigation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of localizing in-breast lesions using the Envisio Navigation and SmartClip system in surgery - Radiologist Cohort
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.
Measured: 1 year
Ability of localizing in-breast lesions using the Envisio Navigation and SmartClip system in surgery - Surgeon Cohort
Questions 4, 5, 6, 8, 9, 10, \& 11 from the Surgeon survey will evaluate the EnVisio system for reproducible in-breast tumor localization by the performing physicians.
Measured: 1 year
Secondary outcomes (4)
Placement of the SmartClip on preoperative imaging to clip location on specimen radiography
Radiologists will take radiologist questionnaire evaluating their experience using the SmartClip
Measured: 1 year
Placement and visibility of the clip by breast radiologists
Radiologists will take radiologist questionnaire evaluating their experience using the SmartClip
Measured: 1 year
Intraoperative use of the device system by surgeons
Surgeons will take surgeon questionnaire evaluating their experience using the SmartClip and EnVisio™ Navigation System
Measured: 1 year
Surgical outcomes with use of the SmartClip
Surgeons will take surgeon questionnaire evaluating their experience using the SmartClip and EnVisio™ Navigation System
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start27 Oct 2020
- Primary completion26 Jul 2023
- Study completion26 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Elucent Medical
- Responsible party
- Sponsor
- Investigators
- M. Catherine Lee, MD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04604561
- Sponsor's protocol ID
- MCC-20335
- Status last verified
- Mar 2026
- First submitted
- 9 Oct 2020
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physician Initiated Evaluation of EnVisio SmartClip for Intraoperative Localization of Breast Masses
- ClinicalTrials.gov ID
- NCT04604561
- Acronym / sponsor ID
- MCC-20335
- Conditions
- Breast Cancer
- Keywords
- SmartClip, EnVisio™ Navigation System
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Elucent Medical
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- 26 Jul 2023 (actual)
- Study completion
- 26 Jul 2023 (actual)
- First posted
- 27 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Participants receiving SmartClip | – | Device: EnVisio SmartClip, Device: EnVisio™ Navigation SystemParticipants 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. |
| Radiologist Placing SmartClip | – | Device: EnVisio SmartClip, Device: EnVisio™ Navigation SystemRadiologist 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. |
| Surgeon | – | Device: EnVisio SmartClip, Device: EnVisio™ Navigation SystemThe surgeon will use the EnVisio™ Navigation System to identify the SmartClip and the targeted lesion for resection. Immediately post-procedure, the performing surgeon will fill out a questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited to this study from the Moffitt Cancer Center Comprehensive Breast Clinic. Patients are seen in this clinic by breast surgeons from the Comprehensive Breast Program at Moffitt Cancer Center.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnVisio SmartClipThe 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 | Participants receiving SmartClip, Radiologist Placing SmartClip, Surgeon |
| EnVisio™ Navigation SystemThe 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. | Device | Participants receiving SmartClip, Radiologist Placing SmartClip, Surgeon |
Primary outcome
Ability of localizing in-breast lesions using the Envisio Navigation and SmartClip system in surgery - Radiologist Cohort
Time frame: 1 year
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.
Ability of localizing in-breast lesions using the Envisio Navigation and SmartClip system in surgery - Surgeon Cohort
Time frame: 1 year
Questions 4, 5, 6, 8, 9, 10, \& 11 from the Surgeon survey will evaluate the EnVisio system for reproducible in-breast tumor localization by the performing physicians.
4 secondary outcomes
Placement of the SmartClip on preoperative imaging to clip location on specimen radiography
Time frame: 1 year
Placement and visibility of the clip by breast radiologists
Time frame: 1 year
Intraoperative use of the device system by surgeons
Time frame: 1 year
Surgical outcomes with use of the SmartClip
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. Catherine Lee, MD principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability of localizing in-breast lesions using the Envisio Navigation and SmartClip system in surgery - Radiologist Cohort (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.