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Completed

NCT Number: NCT04398537

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

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.

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Key information

Conditions

Breast Biopsy

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

5mm retraction of clip deployment apparatus.

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.

Device

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

Primary outcomes

  1. Number of Breast Biopsy Patients Whose Clip Migrated Greater Than 10mm From the Biopsy Site.

    Time frame: 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.

  2. Percentage of Breast Biopsy Patients Whose Clip Migrated Greater Than 10mm From the Biopsy Site.

    Time frame: baseline through 1 hour (post biopsy mammogram/procedure)

  3. Average Distance of Clip Migration for the Arm That Received 5mm Retraction.

    Time frame: baseline through 1 hour (post biopsy mammogram/procedure)

  4. Average Distance of Clip Migration for the Arm That Did Not Receive Clip Retraction.

    Time frame: baseline through 1 hour (post biopsy mammogram/procedure)

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
May 21, 2020
Registry last updated
Dec 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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