Non-palpable Breast LesionsNCT01574664
Evaluation of RFID Localization System for Marking and Retrieving Breast Lesions
An observational study of Non-palpable Breast Lesions, run by Health Beacons at 3 sites in United States.
Trial summary
The goal of this investigation is to obtain clinical data to show the Health Beacons Radiofrequency Identification (RFID) Localization System is safe and performs as intended as a localization device for marking and retrieving a non-palpable surgical target from the breast. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Non-palpable Breast Lesions
- What is being tested?
- RFID Tag (Health Beacon)
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2012to Jun 2017
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Female patients
Who may be able to join
- Have had stereotactic or ultrasound-guided biopsy with marker placement
- Have a lesion or biopsy marker that is visible under ultrasound
- Have surgical target < 6 cm from the skin when lying supine
- Have a discreet surgical target
- Have a lesion in which the center/focal area is defined
- Be at least 18 years of age or older
Who cannot join
- Have a palpable lesion that does not require localization
- Require more than one localization needle for localization of the surgical target
- Have undergone previous open surgical biopsy or lumpectomy in the operative breast
- Have an implant in the operative breast
- Have a cardiac pacemaker or defibrillator device
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Exempla Healthcare
Denver, Colorado, 80218
Sharp Memorial Hospital
San Diego, California, 92123
Harbor-UCLA Medical Center
Torrance, California, 90502
About this study
Official title: A Prospective, Single-Arm, Multicenter Clinical Study to Evaluate the Safety and Performance of the Health Beacons Radiofrequency Identification (RFID) Localization System for Marking and Retrieving Non-Palpable Breast Lesions
The goal of this investigation is to obtain clinical data to show the Health Beacons Radiofrequency Identification (RFID) Localization System is safe and performs as intended as a localization device for marking and retrieving a non-palpable surgical target from the breast.
- Conditions
- Non-palpable Breast Lesions
- Being tested
- RFID Tag (Health Beacon)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RFID Tag (Health Beacon)Device
The radiologist or surgeon will place the Health Beacons RFID Tag under ultrasonic or stereotactic guidance. The surgeon will use the Tagfinder to locate the lesion.
| Study group | Role | What they receive |
|---|---|---|
| Subjects scheduled to undergo lumpectomy | Not described Receives: Device: RFID Tag (Health Beacon) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The surgical target is visualized in the removed specimen AND the RFID Tag was removed from the patient's breast.
The study endpoints are known soon after the lumpectomy procedure by 1) confirmation of the pathology lab examination; and 2) retrieval of the implanted RFID tag.
Measured: Within 96 hours after lumpectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startSep 2012
- Primary completionMar 2017 (estimated)
- Study completionJun 2017 (estimated)
Why it stopped: Not required to be registered
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-palpable 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health Beacons
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Murray Reicher, MD, Study director, Health Beacons
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574664
- Sponsor's protocol ID
- S10-001
- Status last verified
- May 2020
- First submitted
- 3 Apr 2012
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm, Multicenter Clinical Study to Evaluate the Safety and Performance of the Health Beacons Radiofrequency Identification (RFID) Localization System for Marking and Retrieving Non-Palpable Breast Lesions
- ClinicalTrials.gov ID
- NCT01574664
- Acronym / sponsor ID
- S10-001
- Conditions
- Non-palpable Breast Lesions
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Not required to be registered
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Health BeaconsIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 10 Apr 2012 (estimated)
- 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 goal of this investigation is to obtain clinical data to show the Health Beacons Radiofrequency Identification (RFID) Localization System is safe and performs as intended as a localization device for marking and retrieving a non-palpable surgical target from the breast.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects scheduled to undergo lumpectomy | – | Device: RFID Tag (Health Beacon) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Female patients
Key inclusion criteria (6 listed)
- Have had stereotactic or ultrasound-guided biopsy with marker placement
- Have a lesion or biopsy marker that is visible under ultrasound
- Have surgical target < 6 cm from the skin when lying supine
- Have a discreet surgical target
- Have a lesion in which the center/focal area is defined
Key exclusion criteria (5 listed)
- Have a palpable lesion that does not require localization
- Require more than one localization needle for localization of the surgical target
- Have undergone previous open surgical biopsy or lumpectomy in the operative breast
- Have an implant in the operative breast
- Have a cardiac pacemaker or defibrillator device
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 |
|---|---|---|
| RFID Tag (Health Beacon)The radiologist or surgeon will place the Health Beacons RFID Tag under ultrasonic or stereotactic guidance. The surgeon will use the Tagfinder to locate the lesion. | Device | Subjects scheduled to undergo lumpectomy |
Primary outcome
The surgical target is visualized in the removed specimen AND the RFID Tag was removed from the patient's breast.
Time frame: Within 96 hours after lumpectomy
The study endpoints are known soon after the lumpectomy procedure by 1) confirmation of the pathology lab examination; and 2) retrieval of the implanted RFID tag.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
Related trials for Non-palpable Breast Lesions
RecruitingObservational study
MEthods for LOcalization of Different Types of Breast Lesions
Breast Cancer
Active, not recruitingObservational study
Different Localization Techniques for Non-palpable Breast Lesions Comparison: a Retrospective and Multicentric Clinical Study
Breast Cancer
Active, not recruitingObservational study
Comparison Between ROLL Versus Magnetic Seed for Preoperative Localization of Non-palpable Breast Lesion by Randomized Clinical Study.
Breast Cancer
Active, not recruitingObservational study
ROLL Versus Magnetic Seed for Preoperative Localization of Non-palpable Breast Lesion: Comparison Between Techniques.
Breast Cancer
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.
Murray Reicher, MD study director
Health Beacons
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-palpable Breast Lesions, run by Health Beacons at 3 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 6 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: withdrawn, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 withdrawn before enrolling participants, so there are no results.
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?
The surgical target is visualized in the removed specimen AND the RFID Tag was removed from the patient's breast. (time frame: Within 96 hours after lumpectomy). 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 21 May 2020.