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Single Arm Study Group for Prostate Cancer

Phase 3
Waitlist Available
Led By Vipul R Patel, MD
Research Sponsored by AdventHealth
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days to 12 months post prostatectomy
Awards & highlights

Summary

This trial is testing BioDFence® G3, a special amniotic membrane, on prostate cancer patients having robotic-assisted surgery. The goal is to see if it helps them recover sexual and urinary functions more quickly by protecting and healing tissues during the operation.

Eligible Conditions
  • Prostate Cancer
  • Prostatectomy
  • Erectile Dysfunction
  • Urinary Incontinence

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days to 12 months post prostatectomy
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days to 12 months post prostatectomy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to potency
Secondary outcome measures
Time to continence

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single Arm Study GroupExperimental Treatment1 Intervention
Placement of a sheet of BioDFence G3 to the neurovascular bundle.

Find a Location

Who is running the clinical trial?

AdventHealthLead Sponsor
109 Previous Clinical Trials
30,405 Total Patients Enrolled
1 Trials studying Prostate Cancer
128 Patients Enrolled for Prostate Cancer
Integra LifeSciences CorporationIndustry Sponsor
85 Previous Clinical Trials
9,829 Total Patients Enrolled
1 Trials studying Prostate Cancer
240 Patients Enrolled for Prostate Cancer
Vipul R Patel, MDPrincipal InvestigatorAdventHealth
1 Previous Clinical Trials
100 Total Patients Enrolled
~0 spots leftby Sep 2025
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