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

NCT04398537 | Completed Results FDA Device

• 1 other identifier: R20-040
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Biopsy

Keywords

stereostatic procedure

Outcome Measures

Primary Outcomes (4)

• 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)

Study Arms (2)

5mm retraction of clip deployment apparatus

EXPERIMENTAL

The participants in this group will have clip placement 5mm in front of the biopsy site site.

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.

Device: No retraction of clip deployment apparatus.

Interventions

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.

5mm retraction of clip deployment apparatus

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.

no retraction of clip deployment apparatus

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Females 18-99 of age with recommendation for stereotactic biopsy.

You may not qualify if:

• Non-female patients
• Patients \< 18 years old
• Women who are pregnant

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

The University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

Related Publications (1)

• 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.

  PMID: 39236047 DERIVED

Results Point of Contact

• Title: Stefanie Woodard
• Organization: University of Alabama at Birmingham

swoodard@uabmc.edu

205-996-4132

Study Officials

• Stefanie Woodard, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Program Director, Diagnostic Radiology Residency Program Assistant Professor, Breast Imaging Section

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 21, 2020
• Study Start: August 3, 2020
• Primary Completion: January 14, 2022
• Study Completion: July 26, 2023
• Last Updated: December 20, 2023
• Results First Posted: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)