BioDFence® G3 For Full Nerve-Sparing Robotic-Assisted Radical Prostatectomy

The purpose of this study is to assess functional outcomes post operatively after the use of BioDFence® G3 during robotic radical prostatectomy.

Sex

Male

Minimum age

40 Years

Maximum age

70 Years

Inclusion Criteria:

1. Male subjects between the ages 40-70.
2. Primary diagnosis of prostate cancer requiring surgical intervention
3. Have a willingness to comply with follow-up requirements.
4. Have ability to provide full written consent.
5. Primary diagnosis of untreated with clinically localized prostate cancer with Gleason score of 6, or 7.
6. Planned elective radical prostatectomy with bilateral full nerve sparing technique.
7. Patients who currently have a pre-operative SHIM \> 19

Exclusion Criteria:

1. Has signs or symptoms of any other disease which could result in allograft failure or has experienced graft failure in the past.
2. Has any condition(s), which seriously compromises the subject's ability to participate in this study or has a known history of poor adherence with medical treatment.
3. Has comorbid conditions that can be confused with or can exacerbate the condition of erectile dysfunction, including:

   1. Diabetes Type I or Type II
   2. Advanced atherosclerotic vascular disease
4. Is unable to sign or understand informed consent.
5. Is unable to comply with penile rehabilitation, including oral 5-phosphodiesterase inhibitor.
6. Has a documented medical history of drug or alcohol abuse within last 12 months.
7. Has autoimmune disease or a known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.
8. Known sensitivity to glutaraldehyde or ethanol.
9. 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.
10. Has had prior hormonal therapy such as Lupron or oral anti-androgens.
11. Living outside of United States
12. Partial nerve sparing technique used during Radical Prostatectomy

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• BACKGROUNDPatel VR, Samavedi S, Bates AS, Kumar A, Coelho R, Rocco B, Palmer K. Dehydrated Human Amnion/Chorion Membrane Allograft Nerve Wrap Around the Prostatic Neurovascular Bundle Accelerates Early Return to Continence and Potency Following Robot-assisted Radical Prostatectomy: Propensity Score-matched Analysis. Eur Urol. 2015 Jun;67(6):977-980. doi: 10.1016/j.eururo.2015.01.012. Epub 2015 Jan 19. PMID 25613153
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