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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

Study Summary

This trialis testing if a new medical device improves prostate surgery recovery time.

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
106 Previous Clinical Trials
29,537 Total Patients Enrolled
1 Trials studying Prostate Cancer
128 Patients Enrolled for Prostate Cancer
Integra LifeSciences CorporationIndustry Sponsor
84 Previous Clinical Trials
9,489 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Florida
Pennsylvania
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
AdventHealth
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Help with my ED.
PatientReceived 2+ prior treatments
Recent research and studies
European UrologyJournal
Dehydrated Human Amnion/chorion Membrane Allograft Nerve Wrap Around the Prostatic Neurovascular Bundle Accelerates Early Return to Continence and Potency Following Robot-assisted Radical Prostatectomy: Propensity Score–matched Analysis
Patel, Vipul R., Srinivas Samavedi, Anthony S. Bates, Anup Kumar, Rafael Coelho, Bernardo Rocco, and Kenneth Palmer. 2015. “Dehydrated Human Amnion/chorion Membrane Allograft Nerve Wrap Around the Prostatic Neurovascular Bundle Accelerates Early Return to Continence and Potency Following Robot-assisted Radical Prostatectomy: Propensity Score–matched Analysis”. European Urology. Elsevier BV. doi:10.1016/j.eururo.2015.01.012.
Journal of UrologyJournal
Potency Following Robotic Radical Prostatectomy: A Questionnaire Based Analysis of Outcomes After Conventional Nerve Sparing and Prostatic Fascia Sparing Techniques
MENON, MANI, SANJEEV KAUL, AKSHAY BHANDARI, ALOK SHRIVASTAVA, ASHUTOSH TEWARI, and ASHOK HEMAL. 2005. “Potency Following Robotic Radical Prostatectomy: A Questionnaire Based Analysis of Outcomes After Conventional Nerve Sparing and Prostatic Fascia Sparing Techniques”. Journal of Urology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.ju.0000181825.54480.eb.
clinicaltrials.govStudy
BioDFence® G3 For Full Nerve-Sparing Robotic-Assisted Radical Prostatectomy
Vipul Patel, MD 2023. "BioDFence® G3 For Full Nerve-Sparing Robotic-Assisted Radical Prostatectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05363644.
~0 spots leftby Apr 2025
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