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Randomized AmnioFix Study During Radical Prostatectomy

NCT02645591 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2016-11-22

No results posted yet for this study

Summary

The goal of this clinical research study is to learn about the safety and the effectiveness of using AmnioFix® (dehydrated human amnion/chorion membrane, also called dHACM) to help improve the return of erectile function and bladder control in patients after robotic assisted laparoscopic radical prostatectomy (RARP).

dHACM is a section of tissue made from part of the placenta donated by a mother during a C-section. It looks like a small piece of tissue paper and is wrapped around the nerve bundles in the surgical area. The tissue may help the body's normal healing process.

Conditions

Interventions

PROCEDURE

Robotic Assisted Laparoscopic Radical Prostatectomy (RARP)

Participants receive Nerve Sparing robotic assisted laparoscopic radical prostatectomy (RARP).

BIOLOGICAL

AmnioFix®

Dehydrated human amnion/chorion membrane (dHACM) wrapped around the nerve bundles at the end of Nerve Sparing robotic assisted laparoscopic radical prostatectomy (RARP) surgery.

BEHAVIORAL

Questionnaire

Questionnaire completed about erectile function before surgery, and at 6 weeks, 3 months, 6 months, and 12 months after surgery.

Sponsors & Collaborators

  • MiMedx Group, Inc.

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • John W. Davis, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2019-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02645591 on ClinicalTrials.gov