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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03323021
Other study ID # AFSUR001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 23, 2017
Est. completion date February 21, 2019

Study information

Verified date November 2020
Source MiMedx Group, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date February 21, 2019
Est. primary completion date February 21, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Other:
Dehydrated human amnion/chorion membrane
dehydrated human amnion/chorion membrane
Standard of Care
Standard of Care

Locations

Country Name City State
United States The Mount Sinai Hospital New York New York

Sponsors (1)

Lead Sponsor Collaborator
MiMedx Group, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recovery of Renal Function Evaluation of GlomerularFiltration Rate (GFR) 12 months
Secondary Preservation of Renal Parenchymal Volume Using radiologic computed tomography measurements 12 months
Secondary Cancer Control Rates Observed recurrence rate 12 months
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