NCT04398537

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 245 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2020-08-03
• Primary completion: 2022-01-14
• Completion: 2023-07-26
• First posted: 2020-05-21
• Last updated: 2023-12-20
• Results posted: 2023-12-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study