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

NCT05363644 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2023-06-29

No results posted yet for this study

Summary

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

Conditions

  • Prostate Cancer
  • Prostatectomy
  • Erectile Dysfunction Following Radical Prostatectomy
  • Incontinence, Urinary

Interventions

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.

Sponsors & Collaborators

  • Integra LifeSciences Corporation

    collaborator INDUSTRY

  • AdventHealth

    lead OTHER

Principal Investigators

  • Vipul R Patel, MD · AdventHealth

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2023-12-31
Completion
2024-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05363644 on ClinicalTrials.gov