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After partial nephrectomy, kidney function decreases by about 10% overall and by about 20% in the operated kidney. This is primarily due to the loss of healthy parenchymal volume during resection of the tumor. In an effort to preserve and regenerate healthy parenchyma during the procedure and ultimately renal function after partial nephrectomy, the single center double arm single-blinded randomized screening clinical trial will evaluate the ability of human amnion/chorion allograft to facilitate the recovery of renal function following robotic partial nephrectomy.
To determine whether Amniofix facilitates improved recovery of renal function at 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with DHACM | Experimental | Partial nephrectomy patched with DHACM |
|
| Control without DHACM | Active Comparator | Partial nephrectomy without DHACM. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dehydrated human amnion/chorion membrane | Other | dehydrated human amnion/chorion membrane |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recovery of Renal Function | Evaluation of GlomerularFiltration Rate (GFR) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Preservation of Renal Parenchymal Volume | Using radiologic computed tomography measurements | 12 months |
| Cancer Control Rates | Observed recurrence rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ketan Badani, MD | Mt. Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Mount Sinai Hospital | New York | New York | 10029 | United States |
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| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of Care | Other | Standard of Care |
|
| 12 months |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |