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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5mm retraction of clip deployment apparatus | Experimental | The participants in this group will have clip placement 5mm in front of the biopsy site site. |
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| no retraction of clip deployment apparatus | Active Comparator | These participants will the clip delivered at the biopsy site. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline through 1 hour (post biopsy mammogram/procedure) |
| Percentage of Breast Biopsy Patients Whose Clip Migrated Greater Than 10mm From the Biopsy Site. | baseline through 1 hour (post biopsy mammogram/procedure) | |
| Average Distance of Clip Migration for the Arm That Received 5mm Retraction. | baseline through 1 hour (post biopsy mammogram/procedure) | |
| Average Distance of Clip Migration for the Arm That Did Not Receive Clip Retraction. | baseline through 1 hour (post biopsy mammogram/procedure) |
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Inclusion Criteria:
- Females 18-99 of age with recommendation for stereotactic biopsy.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefanie Woodard, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Alabama at Birmingham | Birmingham | Alabama | 35249 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39236047 | Derived | 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. |
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To be determined.
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| ID | Title | Description |
|---|---|---|
| FG000 | 5mm Retraction of Clip Deployment Apparatus | The participants in this group will have clip placement 5mm in front of the biopsy site site. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 5, 2023 |
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| 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. |
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| FG001 | no Retraction of Clip Deployment Apparatus | These participants will the clip delivered at the biopsy site. No retraction of clip deployment apparatus.: This is one method of standard of care and the clip will be deployed at the biopsy site. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 5mm Retraction of Clip Deployment Apparatus | The participants in this group will have clip placement 5mm in front of the biopsy site site. 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. |
| BG001 | no Retraction of Clip Deployment Apparatus | These participants will the clip delivered at the biopsy site. No retraction of clip deployment apparatus.: This is one method of standard of care and the clip will be deployed at the biopsy site. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | baseline through 1 hour (post biopsy mammogram/procedure) |
|
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| Primary | Percentage of Breast Biopsy Patients Whose Clip Migrated Greater Than 10mm From the Biopsy Site. | Posted | Count of Participants | Participants | baseline through 1 hour (post biopsy mammogram/procedure) |
|
| ||||||||||||||||||||||||||||||||
| Primary | Average Distance of Clip Migration for the Arm That Received 5mm Retraction. | This was only measured on the 5mm retraction group | Posted | Mean | Standard Deviation | mm | baseline through 1 hour (post biopsy mammogram/procedure) |
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| Primary | Average Distance of Clip Migration for the Arm That Did Not Receive Clip Retraction. | This was only measured on the control group | Posted | Mean | Standard Deviation | mm | baseline through 1 hour (post biopsy mammogram/procedure) |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 5mm Retraction of Clip Deployment Apparatus | The participants in this group will have clip placement 5mm in front of the biopsy site site. 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. | 0 | 102 | 0 | 102 | 0 | 102 |
| EG001 | no Retraction of Clip Deployment Apparatus | These participants will the clip delivered at the biopsy site. No retraction of clip deployment apparatus.: This is one method of standard of care and the clip will be deployed at the biopsy site. | 0 | 117 | 0 | 117 | 0 | 117 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stefanie Woodard | University of Alabama at Birmingham | 205-996-4132 | swoodard@uabmc.edu |
| Sep 19, 2023 |
| Prot_SAP_ICF_000.pdf |
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| >=65 years |
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| Male |
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| White Hispanic |
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| White Ethnicity Not reported |
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| White Ethnicity Unknown |
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| Black Non-Hispanic |
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| Black Ethnicity Not Reported |
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| Asian Non-Hispanic |
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| Asian Ethnicity Unknown |
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| Hispanic |
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| Hispanic Non-Hispanic |
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| Decline Race Non-Hispanic |
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| Decline Race Ethnicity Not Reported |
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