NCT03323021

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: MiMedx Group, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Partial Nephrectomy
• Kidney Cancer
• Renal Function Aggravated

Interventions

Type	Name	Description
OTHER	Dehydrated human amnion/chorion membrane	dehydrated human amnion/chorion membrane
OTHER	Standard of Care	Standard of Care

Timeline

• Start date: 2017-05-23
• Primary completion: 2019-02-21
• Completion: 2019-02-21
• First posted: 2017-10-26
• Last updated: 2020-11-13

Locations

1 site across 1 country: United States