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

November 12, 2020 updated by: MiMedx Group, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • The Mount Sinai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MiMedx Group, Inc.

Investigators

  • Principal Investigator: Ketan Badani, MD, Mt. Sinai Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2017

Primary Completion (Actual)

February 21, 2019

Study Completion (Actual)

February 21, 2019

Study Registration Dates

First Submitted

October 24, 2017

First Submitted That Met QC Criteria

October 24, 2017

First Posted (Actual)

October 26, 2017

Study Record Updates

Last Update Posted (Actual)

November 13, 2020

Last Update Submitted That Met QC Criteria

November 12, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFSUR001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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