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

Kidney Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03323021
• Other study ID #: AFSUR001
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Dehydration
• Kidney Cancer
• Kidney Neoplasms
• Partial Nephrectomy
• Renal Function Aggravated

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