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Patients with a desire for nipple reconstruction following breast cancer and breast reconstruction will receive a surgical procedure to reconstruct one or both nipples utilizing the COOK Biodesign® Nipple Reconstruction Cylinder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nipple Reconstruction Cylinder | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nipple reconstruction | Device | Biodesign® Nipple Reconstruction Cylinder |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Nipple Projection at 12 Months Compared to Baseline (1 Week Post-procedure) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Patient Satisfaction | Patient satisfaction is defined as patient would recommend the nipple reconstruction operation to others. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geoffrey Gurtner, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States | ||
| Park Meadows Cosmetic Surgery |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nipple Reconstruction Cylinder | Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nipple Reconstruction Cylinder | Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Nipple Projection at 12 Months Compared to Baseline (1 Week Post-procedure) | There were two patients (three nipples) without plastic surgery matrix in place at 12MO. | Posted | Mean | Standard Deviation | percentage of projection vs baseline | 12 months | Nipples | Participants |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nipple Reconstruction Cylinder | Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Metastatic breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cylinder extrusion | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason Hodde, Clinical Affairs Manager | Cook Biotech Incorporated | 765-497-3355 | jhodde@cookbiotech.com |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Lone Tree |
| Colorado |
| 80124 |
| United States |
| Mercy Medical Center | Baltimore | Maryland | 21202 | United States |
| Sanford Clinic Plastic and Reconstructive Surgery | Sioux Falls | South Dakota | 57105 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Nipples |
|
|
| Secondary | Rate of Patient Satisfaction | Patient satisfaction is defined as patient would recommend the nipple reconstruction operation to others. | Posted | Number | percentage of patients | 12 months |
|
|
|
| 1 |
| 50 |
| 3 |
| 50 |
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| D017437 |
| Skin and Connective Tissue Diseases |