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5mm retraction of clip deployment apparatus. for Breast Biopsy

N/A

Waitlist Available

Led By Stefanie Woodard, MD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through 1 hour (post biopsy mammogram/procedure)

Awards & highlights

Study Summary

This trial will enroll 250 female patients who are already scheduled for a stereotactic biopsy. They will be randomly assigned to one of two groups, one of which will have a 5 mm retraction of the biopsy clip post-placement. There is no intervention that is not already part of standard care. The trial will last approximately six months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through 1 hour (post biopsy mammogram/procedure)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through 1 hour (post biopsy mammogram/procedure)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 1 hour (post biopsy mammogram/procedure) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

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

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: 5mm retraction of clip deployment apparatusExperimental Treatment1 Intervention

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

Group II: no retraction of clip deployment apparatusActive Control1 Intervention

These participants will the clip delivered at the biopsy site.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

5mm retraction of clip deployment apparatus.

2020

N/A

~250

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Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,583 Previous Clinical Trials

2,279,799 Total Patients Enrolled

Stefanie Woodard, MDPrincipal InvestigatorUniversity of Alabama at Birmingham

1 Previous Clinical Trials

20 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research encompass those who are over four decades old?

"According to the established parameters for this trial, the minimum age of admission is 18 while those aged 99 and below are eligible."

Answered by AI

Would I meet the criteria for admission to this experiment?

"Those who wish to participate in the research must be between 18 and 99 years of age, with biopsy results that meet pre-specified criteria. This trial is set to admit a total of 250 individuals in total."

Answered by AI

How many participants are involved in this experiment?

"That is accurate. According to clinicaltrials.gov, the trial which was first announced on August 3rd 2020 has recently been looking for 250 individuals from a single site."

Answered by AI

Are there any open opportunities to join this research endeavor?

"Indeed, clinicaltrials.gov affirms that this medical trial is presently recruiting members. It was first advertised on August 3rd 2020 and the listing has been updated most recently on August 24th 2022. 250 individuals need to be enrolled at a single site for participation in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Stefanie A. Woodard 2020. "The Role of Pre-deployment Retraction in Decreasing Biopsy Clip Migration During Stereotactic Breast Biopsies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04398537.