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

Not Applicable

Completed

• Conditions: Breast Biopsy
• Interventions: Device: 5mm retraction of clip deployment apparatus.; Device: No retraction of clip deployment apparatus.

• Registration Number: NCT04398537
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-05-18
• Study First Submitted QC: 2020-05-18
• Study First Posted: 2020-05-21
• Study Start: 2020-08-03
• Primary Completion: 2022-01-14
• Study Completion: 2023-07-26
• Results First Submitted: 2023-10-19
• Status Verified: 2023-12
• Results First Submitted QC: 2023-12-19
• Last Update Submitted: 2023-12-19
• Results First Posted: 2023-12-20
• Last Update Posted: 2023-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 245

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5mm retraction of clip deployment apparatus	5mm retraction of clip deployment apparatus.	The participants in this group will have clip placement 5mm in front of the biopsy site site.
no retraction of clip deployment apparatus	No retraction of clip deployment apparatus.	These participants will the clip delivered at the biopsy site.

Primary Outcome Measures

Name	Time	Method
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)
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.
Average Distance of Clip Migration for the Arm That Did Not Receive Clip Retraction.	baseline through 1 hour (post biopsy mammogram/procedure)

Trial Locations

Locations (1)

The University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States