The Role of Pre-deployment Retraction in Decreasing Biopsy Clip Migration During Stereotactic Breast Biopsies

Study Overview
=================
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.

Official Title
-----------------
The Role of Pre-deployment Retraction in Decreasing Biopsy Clip Migration During Stereotactic Breast Biopsies

Conditions
-----------------
Breast Biopsy

Intervention / Treatment
-----------------
* Device: 5mm retraction of clip deployment apparatus.
* Device: No retraction of clip deployment apparatus.


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5mm retraction of clip deployment apparatus<br>The participants in this group will have clip placement 5mm in front of the biopsy site site. | Device: 5mm retraction of clip deployment apparatus.<br>* 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.<br>|
| Active Comparator: no retraction of clip deployment apparatus<br>These participants will the clip delivered at the biopsy site. | Device: No retraction of clip deployment apparatus.<br>* This is one method of standard of care and the clip will be deployed at the biopsy site.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stereostatic procedure