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| ID | Type | Description | Link |
|---|---|---|---|
| 000544990 | Other Grant/Funding Number | Mammotome |
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| Name | Class |
|---|---|
| Mammotome | UNKNOWN |
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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.
Study objectives
Primary objective
Assess the successful retrieval rates of the HydroMARK Plus clip
Secondary objective
Determine the level of satisfaction of the surgeon with the retrieval of the HydroMARK Plus clip
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydromark plus clip placement | Experimental | Patients with a previously placed HydroMARK T3 coil clip or a clip made by another manufacturer and will have a HydroMARK Plus clip placed during the scout localization procedure for this study. Breast surgeons will perform retrieval and then complete a satisfaction survey to compare the two clips. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HydroMARK Plus Clip | Device | Each patient will undergo a breast localization procedure, and a HydroMARK plus clip will be placed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Date of HydroMARK Plus Clip placement to 1 week plus or minus 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Level of satisfaction of the surgeon with the retrieval of the HydroMARK Plus clip. | Surgeon satisfaction will be evaluated using a Likert scale survey. | Date of retrieval surgery to 1 week. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Quenteeria Mooney | Contact | 205-996-1082 | qmooney@uabmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ceren Yalniz, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Kirklin Clinic | Recruiting | Birmingham | Alabama | 35249 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D013525 | Surgical Instruments |
| ID | Term |
|---|---|
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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