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

NCT03323021 | Completed DMC

• 1 other identifier: AFSUR001
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Partial Nephrectomy; Kidney Cancer; Renal Function Aggravated

Outcome Measures

Primary Outcomes (1)

• Recovery of Renal Function

  Evaluation of GlomerularFiltration Rate (GFR)

  12 months

Secondary Outcomes (2)

• Preservation of Renal Parenchymal Volume

  12 months

• Cancer Control Rates

  12 months

Study Arms (2)

Treatment with DHACM

EXPERIMENTAL

Partial nephrectomy patched with DHACM

Other: Dehydrated human amnion/chorion membrane

Control without DHACM

ACTIVE COMPARATOR

Partial nephrectomy without DHACM.

Other: Standard of Care

Interventions

Dehydrated human amnion/chorion membrane OTHER

dehydrated human amnion/chorion membrane

Treatment with DHACM

Standard of Care OTHER

Standard of Care

Control without DHACM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MiMedx Group, Inc.: lead

Study Sites (1)

The Mount Sinai Hospital

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Ketan Badani, MD

  Mt. Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: October 26, 2017
• Study Start: May 23, 2017
• Primary Completion: February 21, 2019
• Study Completion: February 21, 2019
• Last Updated: November 13, 2020

Record last verified: 2020-11

Locations

US (1)