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

The University of Alabama at Birmingham

Status: Completed

Conditions: Breast Biopsy

Treatments: Device: No retraction of clip deployment apparatus.; Device: 5mm retraction of clip deployment apparatus.

Study type: Interventional

Funder types: Other

Identifiers

NCT04398537

R20-040

Details and patient eligibility

About

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.

Enrollment: 245 patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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245 participants in 2 patient groups

5mm retraction of clip deployment apparatus

Experimental group

Description:

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

Treatment:

Device: 5mm retraction of clip deployment apparatus.

no retraction of clip deployment apparatus

Active Comparator group

Description:

These participants will the clip delivered at the biopsy site.

Treatment:

Device: No retraction of clip deployment apparatus.