Breast BiopsyNCT04398537
The Role of Pre-deployment Retraction in Decreasing Biopsy Clip Migration During Stereotactic Breast Biopsies
A study testing 5mm retraction of clip deployment apparatus. and No retraction of clip deployment apparatus. in people with Breast Biopsy, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This will be a single-center prospective randomized control trial that is Institutional Review Board (IRB) approved. The study plans to enroll 250 female patients presenting to the University of Alabama at Birmingham (UAB) for stereotactic biopsy. This study is a prospective and will target approximately 250 patients. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Breast Biopsy
- What is being tested?
- 5mm retraction of clip deployment apparatus. and No retraction of clip deployment apparatus.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2020to 26 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females 18-99 of age with recommendation for stereotactic biopsy.
Who cannot join
- Non-female patients
- Patients < 18 years old
- Women who are pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Alabama at Birmingham
Birmingham, Alabama, 35249
About this study
This will be a single-center prospective randomized control trial that is Institutional Review Board (IRB) approved. The study plans to enroll 250 female patients presenting to the University of Alabama at Birmingham (UAB) for stereotactic biopsy. This study is a prospective and will target approximately 250 patients. This will be a HIPPA-compliant randomized control trial planned on spanning approximately six months' time. Patients will be entered into the study only based on their already scheduled stereotactic biopsy procedure. Patients will be informed of the study and they will be offered the opportunity to participate or not participate in the study. Their participation is completely voluntary. This study will not involve any intervention that is not already a part of standard care. Patients will be randomized to two groups, one group that will undergo clip placement with approximately with a 5 mm retraction of the biopsy clip post-placement and one that will involve no retraction prior to deployment.
- Conditions
- Breast Biopsy
- Being tested
- 5mm retraction of clip deployment apparatus., No retraction of clip deployment apparatus.
- Keywords
- stereostatic procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5mm retraction of clip deployment apparatus.Device
Advancing the clip to the biopsy site and retracting 5 mm and then deploying. This is one method of standard of care and involves depositing the clip after retraction of the deployment apparatus 5 mm.
No retraction of clip deployment apparatus.Device
This is one method of standard of care and the clip will be deployed at the biopsy site.
| Study group | Role | What they receive |
|---|---|---|
| 5mm retraction of clip deployment apparatus | Experimental | The participants in this group will have clip placement 5mm in front of the biopsy site site. Receives: Device: 5mm retraction of clip deployment apparatus. |
| no retraction of clip deployment apparatus | Active comparator | These participants will the clip delivered at the biopsy site. Receives: Device: No retraction of clip deployment apparatus. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Breast Biopsy Patients Whose Clip Migrated Greater Than 10mm From the Biopsy Site.
This number of participants will be counted if their clip migrated more than 10mm from the biopsy site.
Measured: baseline through 1 hour (post biopsy mammogram/procedure)
Percentage of Breast Biopsy Patients Whose Clip Migrated Greater Than 10mm From the Biopsy Site.
Measured: baseline through 1 hour (post biopsy mammogram/procedure)
Average Distance of Clip Migration for the Arm That Received 5mm Retraction.
Measured: baseline through 1 hour (post biopsy mammogram/procedure)
Average Distance of Clip Migration for the Arm That Did Not Receive Clip Retraction.
Measured: baseline through 1 hour (post biopsy mammogram/procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start3 Aug 2020
- Primary completion14 Jan 2022
- Study completion26 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast BiopsyStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefanie A. Woodard, University of Alabama at Birmingham
- Investigators
- Stefanie Woodard, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398537
- Sponsor's protocol ID
- R20-040
- Status last verified
- Dec 2023
- First submitted
- 18 May 2020
- Last updated
- 20 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: To be determined.
Publications
Eltoum N, Zamora K, Murray A, West J Jr, Willis J, Chieh A, Li Y, Li M, Park JM, Woodard S. The Role of Predeployment Retraction in Biopsy Marker Migration During Stereotactic Breast Biopsies: A Randomized Controlled Trial. J Breast Imaging. 2024 Nov 5;6(6):610-620. doi: 10.1093/jbi/wbae050.
PubMed 39236047
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Pre-deployment Retraction in Decreasing Biopsy Clip Migration During Stereotactic Breast Biopsies
- ClinicalTrials.gov ID
- NCT04398537
- Acronym / sponsor ID
- R20-040
- Conditions
- Breast Biopsy
- Keywords
- stereostatic procedure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 14 Jan 2022 (actual)
- Study completion
- 26 Jul 2023 (actual)
- First posted
- 21 May 2020 (actual)
- Results
- Posted 20 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a single-center prospective randomized control trial that is Institutional Review Board (IRB) approved. The study plans to enroll 250 female patients presenting to the University of Alabama at Birmingham (UAB) for stereotactic biopsy. This study is a prospective and will target approximately 250 patients. This will be a HIPPA-compliant randomized control trial planned on spanning approximately six months' time. Patients will be entered into the study only based on their already scheduled stereotactic biopsy procedure. Patients will be informed of the study and they will be offered the opportunity to participate or not participate in the study. Their participation is completely voluntary. This study will not involve any intervention that is not already a part of standard care. Patients will be randomized to two groups, one group that will undergo clip placement with approximately with a 5 mm retraction of the biopsy clip post-placement and one that will involve no retraction prior to deployment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5mm retraction of clip deployment apparatus | Experimental | Device: 5mm retraction of clip deployment apparatus.The participants in this group will have clip placement 5mm in front of the biopsy site site. |
| no retraction of clip deployment apparatus | Active comparator | Device: No retraction of clip deployment apparatus.These participants will the clip delivered at the biopsy site. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Females 18-99 of age with recommendation for stereotactic biopsy.
Key exclusion criteria (3 listed)
- Non-female patients
- Patients < 18 years old
- Women who are pregnant
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 |
|---|---|---|
| 5mm retraction of clip deployment apparatus.Advancing the clip to the biopsy site and retracting 5 mm and then deploying. This is one method of standard of care and involves depositing the clip after retraction of the deployment apparatus 5 mm. | Device | 5mm retraction of clip deployment apparatus |
| No retraction of clip deployment apparatus.This is one method of standard of care and the clip will be deployed at the biopsy site. | Device | no retraction of clip deployment apparatus |
Primary outcome
Number of Breast Biopsy Patients Whose Clip Migrated Greater Than 10mm From the Biopsy Site.
Time frame: baseline through 1 hour (post biopsy mammogram/procedure)
This number of participants will be counted if their clip migrated more than 10mm from the biopsy site.
Percentage of Breast Biopsy Patients Whose Clip Migrated Greater Than 10mm From the Biopsy Site.
Time frame: baseline through 1 hour (post biopsy mammogram/procedure)
Average Distance of Clip Migration for the Arm That Received 5mm Retraction.
Time frame: baseline through 1 hour (post biopsy mammogram/procedure)
Average Distance of Clip Migration for the Arm That Did Not Receive Clip Retraction.
Time frame: baseline through 1 hour (post biopsy mammogram/procedure)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39236047Eltoum N, Zamora K, Murray A, West J Jr, Willis J, Chieh A, Li Y, Li M, Park JM, Woodard S. The Role of Predeployment Retraction in Biopsy Marker Migration During Stereotactic Breast Biopsies: A Randomized Controlled Trial. J Breast Imaging. 2024 Nov 5;6(6):610-620. doi: 10.1093/jbi/wbae050.
- Individual participant dataSharing planned: No. To be determined.
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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.
Stefanie Woodard, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5mm retraction of clip deployment apparatus. and No retraction of clip deployment apparatus. in people with Breast Biopsy, run by University of Alabama at Birmingham 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 1 inclusion and 3 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 20 Dec 2023. 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?
Yes. Results are posted in the registry (first posted 20 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Breast Biopsy Patients Whose Clip Migrated Greater Than 10mm From the Biopsy Site. (time frame: baseline through 1 hour (post biopsy mammogram/procedure)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04398537, which also lists 1 linked publication.
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 20 Dec 2023.