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Completed

NCT Number: NCT03323021

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

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Key information

Conditions

Partial Nephrectomy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Cancer Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Renal Function Aggravated Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Mount Sinai Hospital

New York, 10029, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dehydrated human amnion/chorion membrane

Other

dehydrated human amnion/chorion membrane

Standard of care

Other

Standard of Care

Primary outcomes

  1. Recovery of Renal Function

    Time frame: 12 months

    Evaluation of GlomerularFiltration Rate (GFR)

Secondary outcomes

  1. Preservation of Renal Parenchymal Volume

    Time frame: 12 months

    Using radiologic computed tomography measurements

  2. Cancer Control Rates

    Time frame: 12 months

    Observed recurrence rate

Sponsors and collaborators

Lead sponsor

MiMedx Group, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 26, 2017
Registry last updated
Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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