BioDFence® G3 For Full Nerve-Sparing Robotic-Assisted Radical Prostatectomy

Overseen By Tadzia Harvey, RN,BSA

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: AdventHealth

Must be taking: 5-phosphodiesterase inhibitors

Must not be taking: Immuno-suppressants, Cytotoxic chemotherapy

Disqualifiers: Diabetes, Atherosclerosis, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on immuno-suppressants, chemotherapy, or hormonal therapy, you may not be eligible to participate.

Research Team

Vipul R Patel, MD

Principal Investigator

AdventHealth

Eligibility Criteria

Inclusion Criteria

Primary diagnosis of prostate cancer requiring surgical intervention

Have a willingness to comply with follow-up requirements.

Male subjects between the ages 40-70.

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 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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

BioDFence® G3 is placed on the neurovascular bundles during robotic-assisted radical prostatectomy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for functional outcomes post-operatively, including potency and continence

12 months

Regular follow-up visits

Treatment Details

Interventions

• BioDFence G3

Participant Groups

Group I: Single Arm Study Group Experimental Treatment 1 Intervention

Placement of a sheet of BioDFence G3 to the neurovascular bundle.

Who Is Running the Clinical Trial?

AdventHealth

Lead Sponsor

Trials

118

Recruited

31,800+

Integra LifeSciences Corporation

Industry Sponsor

Trials

110

Recruited

11,300+

Mojdeh Poul

Integra LifeSciences Corporation

Chief Executive Officer

Bachelor’s and Master’s degrees in Mechanical Engineering from the University of Louisville, MBA from the University of North Carolina at Chapel Hill

Dr. Lisa Egbuonu-Davis

Integra LifeSciences Corporation

Chief Medical Officer since 2023

MD from Harvard Medical School