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

Withdrawn before enrolling · Phase 3

Conditions studied: Prostate Cancer, Prostatectomy, Erectile Dysfunction Following Radical Prostatectomy, Incontinence, Urinary

In brief

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

Key facts

Study ID: NCT05363644
Run by: AdventHealth
People needed: 0
Starts: 2023-04-01
Expected to finish: 2024-06-30
Last updated by the study team: 2023-06-29

Who can join

Age: 40 and older, up to 70. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

Has signs or symptoms of any other disease which could result in allograft failure or has experienced graft failure in the past.
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.
Has comorbid conditions that can be confused with or can exacerbate the condition of erectile dysfunction, including:
Diabetes Type I or Type II
Advanced atherosclerotic vascular disease
Is unable to sign or understand informed consent.
Is unable to comply with penile rehabilitation, including oral 5-phosphodiesterase inhibitor.
Has a documented medical history of drug or alcohol abuse within last 12 months.
Has autoimmune disease or a known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.
Known sensitivity to glutaraldehyde or ethanol.
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.
Has had prior hormonal therapy such as Lupron or oral anti-androgens.
Living outside of United States
Partial nerve sparing technique used during Radical Prostatectomy

Where it is running

AdventHealth — Celebration, Florida, United States

Full record on ClinicalTrials.gov

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