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

NCT ID: NCT04398537

Last Updated: 2023-12-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

245 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-03

Study Completion Date

2023-07-26

Brief Summary

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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

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Conditions

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Breast Biopsy

Keywords

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stereostatic procedure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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5mm retraction of clip deployment apparatus

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

Group Type EXPERIMENTAL

5mm retraction of clip deployment apparatus.

Intervention Type 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.

no retraction of clip deployment apparatus

These participants will the clip delivered at the biopsy site.

Group Type ACTIVE_COMPARATOR

No retraction of clip deployment apparatus.

Intervention Type DEVICE

This is one method of standard of care and the clip will be deployed at the biopsy site.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Stefanie A. Woodard

Assistant Program Director, Diagnostic Radiology Residency Program Assistant Professor, Breast Imaging Section

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stefanie Woodard, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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The University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 39236047 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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R20-040

Identifier Type: -

Identifier Source: org_study_id