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Improved Successful Retrieval Rate of HydroMARK Plus Breast Biopsy Site Marker in Comparison to HydroMARK as Well as Improved Surgeon Satisfaction

ConditionBreast Neoplasm
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-90
SponsorUniversity of Alabama at Birmingham

About this trial

The purpose of the study is to test how successful the retrieval rate of the new HydroMARK Plus Breast Biopsy Site Marker in comparison to HydroMARK.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with biopsy clips scheduled for surgery with SCOUT localization

Disqualifiers

Patients who didn't have surgery, patients younger than 18 years old

Patients older than 90 years old

Inmates

Non-English speakers

Trial design

Design model

Single group

Treatments tested in this trial

  • HydroMARK Plus Clip

    Device

    Each patient will undergo a breast localization procedure, and a HydroMARK plus clip will be placed.

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Hydromark plus clip placementExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Retrieval rate of the HydroMARK Plus clip.

The primary endpoint of HydroMARK Plus retrieval rate will be estimated with % and two-sided 95% CI using normal approximation. A paired McNemar Test will be used to compare HydroMARK Plus retrieval rate and HydroMARK retrieval rate, and the 95% CI for the difference of retrieve rate will be estimated using the Newcombe's Score method.

Time frame
Date of HydroMARK Plus Clip placement to 1 week plus or minus 5 days

Secondary outcomes

1

Level of satisfaction of the surgeon with the retrieval of the HydroMARK Plus clip.

Surgeon satisfaction will be evaluated using a Likert scale survey.

Time frame
Date of retrieval surgery to 1 week.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

Mammotome

Collaborator

Source ClinicalTrials.gov
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