BioDFence® G3 For Full Nerve-Sparing Robotic-Assisted Radical Prostatectomy (NCT05363644) | Clinical Trial Compass
WithdrawnPhase 3
BioDFence® G3 For Full Nerve-Sparing Robotic-Assisted Radical Prostatectomy
Stopped: Study was withdrawn due to lack of funding
United States0Started 2023-04-01
Plain-language summary
The purpose of this study is to assess functional outcomes post operatively after the use of BioDFence® G3 during robotic radical prostatectomy.
Who can participate
Age range40 Years – 70 Years
SexMALE
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Inclusion criteria
✓. 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 criteria
✕. 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.
What they're measuring
1
Time to potency
Timeframe: 14 days to 12 months post prostatectomy