Breast LesionsNCT03520127
A Registry Study Evaluating Outcomes in Breast Biopsy With the Intact™ Breast Lesion Excision System (BLES)
An observational study of Breast Lesions, run by Medtronic Surgical Technologies at 7 sites in United States.
Trial summary
The purpose of this registry study is to collect use and clinical outcomes data following breast lesion excision or sampling with the Intact BLES. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Lesions
- What is being tested?
- Intact Breast Lesion Excision System (BLES)
- Type of treatment
- Medical device
- How many people
- 176 participants
- Where
- 7 sitesUnited States
- Study dates
- 27 Sep 2017to 28 Feb 2019
- How long will I take part?
- 1 Month
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who have undergone the Intact procedure that are female and 18 years of age or older.
Who may be able to join
- Female
- Age ≥ 18 years
- BIRADS ≤ 5, as initially imaged
- Subject is willing and capable of providing informed consent and has a scheduled or planned breast lesion excision or sampling where the Intact BLES is expected to be used
Who cannot join
- Male
- Subjects with subglandular (pre-pectoral, or "single plane") breast implants
- Subjects with electronic implantable devices (such as pacemakers and defibrillators)
- Subjects who are contraindicated for surgery due to factors such as anti-coagulant use which cannot be safely reversed
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Winship Cancer Institute-Emory St. Joseph's
Atlanta, Georgia, 30342
Birmingham Breast Care
Birmingham, Alabama, 35205
The Breast Center at Chesapeake Regional Healthcare
Chesapeake, Virginia, 23320
Dalton Surgical Group
Dalton, Georgia, 30720
Holyoke Medical Center
Holyoke, Massachusetts, 01040
Metro Surgical Associates Inc.
Lithonia, Georgia, 30058
Nashville Breast Center
Nashville, Tennessee, 37203
About this study
Official title: A Multi-center Registry Study Evaluating Outcomes in Breast Biopsy With the Intact™ Breast Lesion Excision System (BLES)
The purpose of this registry study is to collect use and clinical outcomes data following breast lesion excision or sampling with the Intact BLES.
- Conditions
- Breast Lesions
- Being tested
- Intact Breast Lesion Excision System (BLES)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intact Breast Lesion Excision System (BLES)Device
Intact BLES is an automated, percutaneous biopsy device capable of delivering a surgical quality specimen for histological review of breast abnormalities. It is uniquely suited to maintain lesion architecture within the biopsy sample, providing an opportunity for pathological assessment and the potential avoidance of an open surgical procedure.
| Study group | Role | What they receive |
|---|---|---|
| Females, 18 years of age or older | Females, 18 years of age or older, who will undergo the Intact procedure Receives: Device: Intact Breast Lesion Excision System (BLES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion BIRADS score
Diagnostic imaging result
Measured: Weeks prior to the Intact procedure
Imaging lesion size
Measured in mm
Measured: Weeks prior to the Intact procedure
Lesion histology
Lesion biopsy results
Measured: Weeks prior to the Intact procedure
Tissue margin (as reported from histology) rate
Procedure margin vs. margin size, measured in mm
Measured: Weeks after the Intact procedure, up to approximately 12 weeks
Underestimation rate
Compared to maximum lesion size, measured in mm
Measured: Weeks after the Intact procedure, up to approximately 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start27 Sep 2017
- Primary completion15 Feb 2019
- Study completion28 Feb 2019
Why it stopped: Product withdrawn from the market due to a shift in sponsor business focus
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast LesionsStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 176 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Medtronic Surgical Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lydia Sakakeeny, PhD, Study director, Medtronic Surgical Technologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03520127
- Sponsor's protocol ID
- 63-10-2356
- Status last verified
- May 2019
- First submitted
- 5 Apr 2018
- Last updated
- 16 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Registry Study Evaluating Outcomes in Breast Biopsy With the Intact™ Breast Lesion Excision System (BLES)
- ClinicalTrials.gov ID
- NCT03520127
- Acronym / sponsor ID
- 63-10-2356
- Conditions
- Breast Lesions
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Product withdrawn from the market due to a shift in sponsor business focus
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Medtronic Surgical TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2017 (actual)
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 9 May 2018 (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.
The purpose of this registry study is to collect use and clinical outcomes data following breast lesion excision or sampling with the Intact BLES.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Females, 18 years of age or older | – | Device: Intact Breast Lesion Excision System (BLES)Females, 18 years of age or older, who will undergo the Intact procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who have undergone the Intact procedure that are female and 18 years of age or older.
Key inclusion criteria (4 listed)
- Female
- Age ≥ 18 years
- BIRADS ≤ 5, as initially imaged
- Subject is willing and capable of providing informed consent and has a scheduled or planned breast lesion excision or sampling where the Intact BLES is expected to be used
Key exclusion criteria (4 listed)
- Male
- Subjects with subglandular (pre-pectoral, or "single plane") breast implants
- Subjects with electronic implantable devices (such as pacemakers and defibrillators)
- Subjects who are contraindicated for surgery due to factors such as anti-coagulant use which cannot be safely reversed
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 |
|---|---|---|
| Intact Breast Lesion Excision System (BLES)Intact BLES is an automated, percutaneous biopsy device capable of delivering a surgical quality specimen for histological review of breast abnormalities. It is uniquely suited to maintain lesion architecture within the biopsy sample, providing an opportunity for pathological assessment and the potential avoidance of an open surgical procedure. | Device | Females, 18 years of age or older |
Primary outcome
Lesion BIRADS score
Time frame: Weeks prior to the Intact procedure
Diagnostic imaging result
Imaging lesion size
Time frame: Weeks prior to the Intact procedure
Measured in mm
Lesion histology
Time frame: Weeks prior to the Intact procedure
Lesion biopsy results
Tissue margin (as reported from histology) rate
Time frame: Weeks after the Intact procedure, up to approximately 12 weeks
Procedure margin vs. margin size, measured in mm
Underestimation rate
Time frame: Weeks after the Intact procedure, up to approximately 12 weeks
Compared to maximum lesion size, measured in mm
Results and safety
The study was stopped early (reason given: Product withdrawn from the market due to a shift in sponsor business focus). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2019.
- Individual participant dataSharing planned: Undecided
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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.
Lydia Sakakeeny, PhD study director
Medtronic Surgical Technologies
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Lesions, run by Medtronic Surgical Technologies at 7 sites 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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 16 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 was stopped early (reason given: Product withdrawn from the market due to a shift in sponsor business focus). Results are not available in the source record.
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?
Lesion BIRADS score (time frame: Weeks prior to the Intact procedure). The study lists 5 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 16 May 2019.