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

MiMedx

Status: Completed

Conditions: Partial Nephrectomy; Kidney Cancer; Renal Function Aggravated

Treatments: Other: Dehydrated human amnion/chorion membrane; Other: Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT03323021

AFSUR001

Details and patient eligibility

About

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.

Full description

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

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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61 participants in 2 patient groups

Treatment with DHACM

Experimental group

Description:

Partial nephrectomy patched with DHACM

Treatment:

Other: Dehydrated human amnion/chorion membrane

Control without DHACM

Active Comparator group

Description:

Partial nephrectomy without DHACM.

Treatment:

Other: Standard of Care