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

Not Applicable

Completed

• Conditions: Partial Nephrectomy; Kidney Cancer; Renal Function Aggravated
• Interventions: Other: Dehydrated human amnion/chorion membrane; Other: Standard of Care

• Registration Number: NCT03323021
• Lead Sponsor: 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.

Detailed Description

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

Study Timeline

• Study Start: 2017-05-23
• Study First Submitted: 2017-10-24
• Study First Submitted QC: 2017-10-24
• Study First Posted: 2017-10-26
• Primary Completion: 2019-02-21
• Study Completion: 2019-02-21
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-12
• Last Update Posted: 2020-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment with DHACM	Dehydrated human amnion/chorion membrane	Partial nephrectomy patched with DHACM
Control without DHACM	Standard of Care	Partial nephrectomy without DHACM.

Primary Outcome Measures

Name	Time	Method
Recovery of Renal Function	12 months	Evaluation of GlomerularFiltration Rate (GFR)

Secondary Outcome Measures

Name	Time	Method
Cancer Control Rates	12 months	Observed recurrence rate
Preservation of Renal Parenchymal Volume	12 months	Using radiologic computed tomography measurements

Trial Locations

Locations (1)

The Mount Sinai Hospital; 🇺🇸 New York, New York, United States