Status:
WITHDRAWN
BioDFence® G3 For Full Nerve-Sparing Robotic-Assisted Radical Prostatectomy
Lead Sponsor:
AdventHealth
Collaborating Sponsors:
Integra LifeSciences Corporation
Conditions:
Prostate Cancer
Prostatectomy
Eligibility:
MALE
40-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess functional outcomes post operatively after the use of BioDFence® G3 during robotic radical prostatectomy.
Detailed Description
The purpose of this study is to build on our experience of amniotic membrane use in Robotic Assisted Radical Prostatectomy for prostate cancer, we aim to evaluate clinical outcomes related to the use ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05363644
Start Date
April 1 2023
End Date
June 30 2024
Last Update
June 29 2023
Active Locations (1)
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1
AdventHealth
Celebration, Florida, United States, 34747