Randomized Clinical Trial Using Amniotic Membrane in Robotic Assisted Laparoscopic Prostatectomy

NCT01832168 | Completed

• 1 other identifier: AFRALP001
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether the AmnioFix dehydrated human amniotic membrane is effective in protecting nerves in men receiving robotic assisted laparoscopic prostatectomies.

Conditions

Pudendal Nerve

Outcome Measures

Primary Outcomes (1)

• The proportion of patients achieving return to baseline Sexual Health Inventory for Men (SHIM) score in the AmnioFix group versus the Control group.

  4 weeks

Secondary Outcomes (2)

• Time to return of erectile function.

  Up to 6 months

• Pain scores.

  10 days, 4 weeks, 3 months, and 6 months

Study Arms (2)

Control

OTHER

Robotic Assisted Laparoscopic Prostatectomy with application of absorbable hemostat.

Procedure: Robotic Assisted Laparoscopic Prostatectomy; Other: Application of Absorbable Hemostat

AmnioFix

EXPERIMENTAL

Robotic Assisted Laparoscopic Prostatectomy with application of dehydrated human amniotic membrane.

Procedure: Robotic Assisted Laparoscopic Prostatectomy; Other: Application of dehydrated human amniotic membrane

Interventions

Robotic Assisted Laparoscopic Prostatectomy PROCEDURE

Robotic Assisted Laparoscopic Prostatectomy with nerve-sparing technique

AmnioFix; Control

Application of Absorbable Hemostat OTHER

Application of Surgicel® SNoW Absorbable Hemostat by Johnson and Johnson on the neurovascular bundle after removal of the cancerous prostate.

Also known as: Surgicel® SNoW

Control

Application of dehydrated human amniotic membrane OTHER

Application of dehydrated human amniotic membrane (DHAM) on the neurovascular bundle after removal of the cancerous prostate.

Also known as: AmnioFix

AmnioFix

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 45-70
• Clinically localized prostate cancer with Gleason score 6 or 7
• SHIM Score greater than or equal to 16 in the absence of medication
• Feasibility to perform unilateral or bilateral nerve sparing RALP

You may not qualify if:

• Clinically locally advanced cancer and/or with Gleason score 8 or 9.
• Difficulty performing nerve sparing RALP.
• Prior surgery at the site.
• Site exhibits clinical signs and symptoms of infection.
• SHIM score at screening \<16.
• Current use of anticoagulant medication including Coumadin, Plavix, etc.
• Has had "salvage prostatectomy" - patients who failed prior therapies including external radiation therapy, cryotherapy, etc.
• Has prior radiation therapy treatment at the site.
• Prior hormonal therapy such as Lupron or oral anti-androgens.
• Non-mobile, i.e. not ambulatory or bed ridden.
• The presence of comorbidities that can be confused with or can exacerbate the condition including:
• diabetes
• advanced atherosclerotic vascular disease
• Patients with a history of more than two weeks treatment with immuno-suppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
• Patients on any investigational drug(s) or therapeutic device(s) within 30 days preceding screening.

Sponsors & Collaborators

• MiMedx Group, Inc.: lead

Study Sites (1)

Jackson South Urology Center of Excellence

Miami, Florida, 33176, United States

Location

Study Officials

• Sanjay Razdan, MD

  Jackson South Urology Center of Excellence

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2013
• First Posted: April 15, 2013
• Study Start: February 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: March 17, 2015

Record last verified: 2015-03

Locations

US (1)