Breast Biopsy
Conditions
Keywords
stereostatic procedure
Brief 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. 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.
Interventions
DEVICE5mm 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.
DEVICENo retraction of clip deployment apparatus.
This is one method of standard of care and the clip will be deployed at the biopsy site.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
\- Females 18-99 of age with recommendation for stereotactic biopsy.
Exclusion criteria
* Non-female patients * Patients \< 18 years old * Women who are pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Breast Biopsy Patients Whose Clip Migrated Greater Than 10mm From the Biopsy Site. | 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. | 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) | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 102 |
| 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. | 117 |
| Total | 219 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 10 | 15 |
Baseline characteristics
| Characteristic | Total | 5mm Retraction of Clip Deployment Apparatus | no Retraction of Clip Deployment Apparatus |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 88 Participants | 42 Participants | 46 Participants |
| Age, Categorical Between 18 and 65 years | 131 Participants | 60 Participants | 71 Participants |
| Race/Ethnicity, Customized Asian Ethnicity Unknown | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Asian Non-Hispanic | 17 participants | 7 participants | 10 participants |
| Race/Ethnicity, Customized Black Ethnicity Not Reported | 2 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Black Non-Hispanic | 66 participants | 33 participants | 33 participants |
| Race/Ethnicity, Customized Decline Race Ethnicity Not Reported | 5 participants | 3 participants | 2 participants |
| Race/Ethnicity, Customized Decline Race Non-Hispanic | 10 participants | 4 participants | 6 participants |
| Race/Ethnicity, Customized Hispanic | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Hispanic Non-Hispanic | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized White Ethnicity Not reported | 5 participants | 3 participants | 2 participants |
| Race/Ethnicity, Customized White Ethnicity Unknown | 2 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized White Hispanic | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized White Non-Hispanic | 108 participants | 49 participants | 59 participants |
| Sex: Female, Male Female | 219 Participants | 102 Participants | 117 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 102 | 0 / 117 |
| other Total, other adverse events | 0 / 102 | 0 / 117 |
| serious Total, serious adverse events | 0 / 102 | 0 / 117 |
Outcome results
Primary
Average Distance of Clip Migration for the Arm That Did Not Receive Clip Retraction.
Time frame: baseline through 1 hour (post biopsy mammogram/procedure)
Population: This was only measured on the control group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| no Retraction of Clip Deployment Apparatus | Average Distance of Clip Migration for the Arm That Did Not Receive Clip Retraction. | 9.8 mm | Standard Deviation 14.9 |
Primary
Average Distance of Clip Migration for the Arm That Received 5mm Retraction.
Time frame: baseline through 1 hour (post biopsy mammogram/procedure)
Population: This was only measured on the 5mm retraction group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5mm Retraction of Clip Deployment Apparatus | Average Distance of Clip Migration for the Arm That Received 5mm Retraction. | 12.1 mm | Standard Deviation 14.9 |
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.
Time frame: baseline through 1 hour (post biopsy mammogram/procedure)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 5mm Retraction of Clip Deployment Apparatus | Number of Breast Biopsy Patients Whose Clip Migrated Greater Than 10mm From the Biopsy Site. | 46 Participants |
| no Retraction of Clip Deployment Apparatus | Number of Breast Biopsy Patients Whose Clip Migrated Greater Than 10mm From the Biopsy Site. | 44 Participants |
Primary
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 5mm Retraction of Clip Deployment Apparatus | Percentage of Breast Biopsy Patients Whose Clip Migrated Greater Than 10mm From the Biopsy Site. | 46 Participants |
| no Retraction of Clip Deployment Apparatus | Percentage of Breast Biopsy Patients Whose Clip Migrated Greater Than 10mm From the Biopsy Site. | 44 Participants |