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Single Arm Study Group for Prostatectomy

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
No Placebo-Only Group
Pivotal Trial

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to potency
Secondary study objectives
Time to continence

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

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Who is running the clinical trial?

AdventHealthLead Sponsor
115 Previous Clinical Trials
31,365 Total Patients Enrolled
Integra LifeSciences CorporationIndustry Sponsor
108 Previous Clinical Trials
11,294 Total Patients Enrolled
Vipul R Patel, MDPrincipal InvestigatorAdventHealth
1 Previous Clinical Trials
100 Total Patients Enrolled
~0 spots leftby Nov 2025
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