Use of Human Dehydrated Amnion/Chorion (DHACM) Allograft in Partial Nephrectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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To determine whether Amniofix facilitates improved recovery of renal function at 12 months.

Official Title
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A Single-Center Double Arm Single-Blinded Randomized Screening Clinical Trial to Evaluate the Use of Human Dehydrated Amnion/Chorion Membrane to Facilitate the Recovery of Renal Function Following Robotic Partial Nephrectomy

Conditions
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Partial Nephrectomy, Kidney Cancer, Renal Function Aggravated

Intervention / Treatment
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* Other: Dehydrated human amnion/chorion membrane
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any individual with a diagnosis of a renal mass. All Patients undergoing partial nephrectomy as their definitive treatment for their renal mass. Ability to understand and the willingness to sign a written informed consent. Patients with a solitary clinical T1a renal mass. Exclusion Criteria: Patients undergoing radical nephrectomy as their definitive treatment for their renal mass. Patients with Transitional Cell Carcinoma. Patients with known hereditary syndromes such Von Hippel-Lindau (VHL) syndrome, Lynch Syndrome, Birt-Hogg-Dube Syndrome. Patients with metastatic disease undergoing cytoreductive nephrectomy as their definitive treatment for metastatic disease. Patients with prior kidney surgery. Patients with a solitary or horseshoe kidney. Patients with a positive margin found during intra-operative frozen section done only when clinically indicated (i.e., macroscopic abnormality identified). Patients with multiple renal masses. Patients with greater than a clinical T1a renal mass.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with DHACM<br>Partial nephrectomy patched with DHACM | Other: Dehydrated human amnion/chorion membrane<br>* dehydrated human amnion/chorion membrane<br>|
| Active Comparator: Control without DHACM<br>Partial nephrectomy without DHACM. | Other: Standard of Care<br>* Standard of Care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery of Renal Function | Evaluation of GlomerularFiltration Rate (GFR) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preservation of Renal Parenchymal Volume | Using radiologic computed tomography measurements | 12 months | 
| Cancer Control Rates | Observed recurrence rate | 12 months |