Status:
COMPLETED
Use of Human Dehydrated Amnion/Chorion (DHACM) Allograft in Partial Nephrectomy
Lead Sponsor:
MiMedx Group, Inc.
Conditions:
Partial Nephrectomy
Kidney Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 t...
Detailed Description
To determine whether Amniofix facilitates improved recovery of renal function at 12 months.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2019
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT03323021
Start Date
May 23 2017
End Date
February 21 2019
Last Update
November 13 2020
Active Locations (1)
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1
The Mount Sinai Hospital
New York, New York, United States, 10029