Back to resultsUse of Human Dehydrated Amnion/Chorion (DHACM) Allograft in Partial Nephrectomy
Primary Purpose
Partial Nephrectomy, Kidney Cancer, Renal Function Aggravated
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dehydrated human amnion/chorion membrane
Standard of Care
Sponsored by
About this trial
This is an interventional treatment trial for Partial Nephrectomy
Eligibility Criteria
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.
Sites / Locations
- The Mount Sinai Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment with DHACM
Control without DHACM
Arm Description
Partial nephrectomy patched with DHACM
Partial nephrectomy without DHACM.
Outcomes
Primary Outcome Measures
Recovery of Renal Function
Evaluation of GlomerularFiltration Rate (GFR)
Secondary Outcome Measures
Preservation of Renal Parenchymal Volume
Using radiologic computed tomography measurements
Cancer Control Rates
Observed recurrence rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03323021
Brief Title
Use of Human Dehydrated Amnion/Chorion (DHACM) Allograft in Partial Nephrectomy
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
May 23, 2017 (Actual)
Primary Completion Date
February 21, 2019 (Actual)
Study Completion Date
February 21, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MiMedx Group, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
To determine whether Amniofix facilitates improved recovery of renal function at 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Nephrectomy, Kidney Cancer, Renal Function Aggravated
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment with DHACM
Arm Type
Experimental
Arm Description
Partial nephrectomy patched with DHACM
Arm Title
Control without DHACM
Arm Type
Active Comparator
Arm Description
Partial nephrectomy without DHACM.
Intervention Type
Other
Intervention Name(s)
Dehydrated human amnion/chorion membrane
Intervention Description
dehydrated human amnion/chorion membrane
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Standard of Care
Primary Outcome Measure Information:
Title
Recovery of Renal Function
Description
Evaluation of GlomerularFiltration Rate (GFR)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Preservation of Renal Parenchymal Volume
Description
Using radiologic computed tomography measurements
Time Frame
12 months
Title
Cancer Control Rates
Description
Observed recurrence rate
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ketan Badani, MD
Organizational Affiliation
Mt. Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Use of Human Dehydrated Amnion/Chorion (DHACM) Allograft in Partial Nephrectomy
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