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

Breast Biopsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04398537
• Other study ID #: R20-040
• Status: Completed
• Phase: N/A
• Start date: August 3, 2020
• Est. completion date: July 26, 2023

Study information

• Verified date: December 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: July 26, 2023
• Est. primary completion date: January 14, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Biopsy

Intervention

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.
• No retraction of clip deployment apparatus.
This is one method of standard of care and the clip will be deployed at the biopsy site.

Locations

Country	Name	City	State
United States	The University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Percentage of Breast Biopsy Patients Whose Clip Migrated Greater Than 10mm From the Biopsy Site.		baseline through 1 hour (post biopsy mammogram/procedure)
Primary	Average Distance of Clip Migration for the Arm That Received 5mm Retraction.		baseline through 1 hour (post biopsy mammogram/procedure)
Primary	Average Distance of Clip Migration for the Arm That Did Not Receive Clip Retraction.		baseline through 1 hour (post biopsy mammogram/procedure)