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

June 28, 2023 updated by: Vipul Patel, MD, AdventHealth

Treatment Protocol With BioDFence® G3 For Full Nerve-Sparing Robotic-Assisted Radical Prostatectomy: A Prospective Open Label Single-Center Study

The purpose of this study is to assess functional outcomes post operatively after the use of BioDFence® G3 during robotic radical prostatectomy.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to build on our experience of amniotic membrane use in Robotic Assisted Radical Prostatectomy for prostate cancer, we aim to evaluate clinical outcomes related to the use of BioDFence® G3; a tri-layered amniotic membrane. BioDFence® G3 is regulated by the FDA as a 361 HCT/P for use from head to toe as a tissue barrier for soft tissue repair and as a wound covering.

For the purpose of this study BioDFence® G3 will be placed on the neurovascular bundles by the surgeon during the robotic assisted radical prostatectomy procedure that the participant has elected as their primary treatment for prostate cancer. The potential benefits that will be assessed are an earlier return of potency after surgery as evidenced by The Sexual Health Inventory for Men (SHIM) questionnaire score and self-reported sexual function and secondarily looking at continence outcomes measured by The American Urological Association (AUA) questionnaire form and self-reported urinary function.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Celebration, Florida, United States, 34747
        • AdventHealth

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male subjects between the ages 40-70.
  2. Primary diagnosis of prostate cancer requiring surgical intervention
  3. Have a willingness to comply with follow-up requirements.
  4. Have ability to provide full written consent.
  5. Primary diagnosis of untreated with clinically localized prostate cancer with Gleason score of 6, or 7.
  6. Planned elective radical prostatectomy with bilateral full nerve sparing technique.
  7. Patients who currently have a pre-operative SHIM > 19

Exclusion Criteria:

  1. Has signs or symptoms of any other disease which could result in allograft failure or has experienced graft failure in the past.
  2. 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.

  3. Has comorbid conditions that can be confused with or can exacerbate the condition of erectile dysfunction, including:

    1. Diabetes Type I or Type II
    2. Advanced atherosclerotic vascular disease
  4. Is unable to sign or understand informed consent.
  5. Is unable to comply with penile rehabilitation, including oral 5-phosphodiesterase inhibitor.
  6. Has a documented medical history of drug or alcohol abuse within last 12 months.
  7. Has autoimmune disease or a known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.
  8. Known sensitivity to glutaraldehyde or ethanol.
  9. Patients with a history of more than two weeks treatment with immuno-suppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
  10. Has had prior hormonal therapy such as Lupron or oral anti-androgens.
  11. Living outside of United States
  12. Partial nerve sparing technique used during Radical Prostatectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Arm Study Group
Placement of a sheet of BioDFence G3 to the neurovascular bundle.
Biological: BioDFence G3
Placement of a sheet of BioDFence® G3 will be applied to the neurovascular bundle on participants undergoing an elective Full Nerve Sparing Radical Prostatectomy for primary treatment of prostate cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to potency
Time Frame: 14 days to 12 months post prostatectomy
Outcome measured by the Sexual Health Inventory for Men (SHIM) score and patient reported potency erectile function score.
14 days to 12 months post prostatectomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to continence
Time Frame: 14 days to 12 months post prostatectomy
Outcome measured by the American Urological Association (AUA ) score and patient reported number of urinary sanitation pads used daily.
14 days to 12 months post prostatectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth

Collaborators

Integra LifeSciences Corporation

Investigators

  • Principal Investigator: Vipul R Patel, MD, AdventHealth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2023

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

April 25, 2022

First Submitted That Met QC Criteria

May 2, 2022

First Posted (Actual)

May 6, 2022

Study Record Updates

Last Update Posted (Actual)

June 29, 2023

Last Update Submitted That Met QC Criteria

June 28, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1803935

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

De-identified information may be utilized in teachings and/or publication as it related to this research.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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