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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03323021
Recruitment Status : Completed
First Posted : October 26, 2017
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
MiMedx Group, Inc.

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 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.

Condition or disease Intervention/treatment Phase
Partial Nephrectomy Kidney Cancer Renal Function Aggravated Biological: Dehydrated human amnion/chorion membrane Other: Standard of Care Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : May 23, 2017
Actual Primary Completion Date : February 21, 2019
Actual Study Completion Date : February 21, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment with DHACM
Partial nephrectomy patched with DHACM
Biological: 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




Primary Outcome Measures :
  1. Recovery of Renal Function [ Time Frame: 12 months ]
    Evaluation of GlomerularFiltration Rate (GFR)


Secondary Outcome Measures :
  1. Preservation of Renal Parenchymal Volume [ Time Frame: 12 months ]
  2. Cancer Control Rates [ Time Frame: 12 months ]
    Observed recurrence rate



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03323021


Locations
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United States, New York
The Mount Sinai Hospital
New York, New York, United States, 10029
Sponsors and Collaborators
MiMedx Group, Inc.
Investigators
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Principal Investigator: Ketan Badani, MD Mt. Sinai Medical Center

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Responsible Party: MiMedx Group, Inc.
ClinicalTrials.gov Identifier: NCT03323021    
Other Study ID Numbers: AFSUR001
First Posted: October 26, 2017    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Neoplasms
Dehydration
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes