Trials / Withdrawn
WithdrawnNCT05363644
BioDFence® G3 For Full Nerve-Sparing Robotic-Assisted Radical Prostatectomy
Treatment Protocol With BioDFence® G3 For Full Nerve-Sparing Robotic-Assisted Radical Prostatectomy: A Prospective Open Label Single-Center Study
- Status
- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- AdventHealth · Academic / Other
- Sex
- Male
- Age
- 40 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess functional outcomes post operatively after the use of BioDFence® G3 during robotic radical prostatectomy.
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.
Conditions
- Prostate Cancer
- Prostatectomy
- Erectile Dysfunction Following Radical Prostatectomy
- Incontinence, Urinary
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-04-01
- Primary completion
- 2023-12-31
- Completion
- 2024-06-30
- First posted
- 2022-05-06
- Last updated
- 2023-06-29
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05363644. Inclusion in this directory is not an endorsement.