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

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 Overview

• Status: Completed
• Conditions: Breast Biopsy
• Intervention / Treatment: Device: 5mm retraction of clip deployment apparatus.; Device: No retraction of clip deployment apparatus.

• Study Type: Interventional
• Enrollment (Actual): 245
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephanie Ford, BS; Phone Number: 205-934-4080; Email: smford@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • The University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

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)

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Stefanie Woodard, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2020
• Primary Completion (Actual): January 14, 2022
• Study Completion (Actual): July 26, 2023

Study Registration Dates

• First Submitted: May 18, 2020
• First Submitted That Met QC Criteria: May 18, 2020
• First Posted (Actual): May 21, 2020

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: stereostatic procedure
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenocorticotropic Hormone; Melanocyte-Stimulating Hormones; beta-Endorphin
• Other Study ID Numbers: R20-040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: To be determined.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes