Status:
COMPLETED
Randomized Clinical Trial Using Amniotic Membrane in Robotic Assisted Laparoscopic Prostatectomy
Lead Sponsor:
MiMedx Group, Inc.
Conditions:
Pudendal Nerve
Eligibility:
MALE
45-70 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
- Unable to comply with penile rehabilitation.
- Known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.
- Patients who are unable to understand the aims and objectives of the trial.
- Presence of any condition(s) which seriously compromises the subject's ability to complete this study, or has a known history of poor adherence with medical treatment.
- Currently taking medications which could affect graft incorporation (supervising physician's discretion).
- Allergic to gentamicin and/or streptomycin.
- Damage to neurovascular bundles during surgery.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01832168
Start Date
February 1 2013
End Date
June 1 2014
Last Update
March 17 2015
Active Locations (1)
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1
Jackson South Urology Center of Excellence
Miami, Florida, United States, 33176