Clinical Research Directory
Browse clinical research sites, groups, and studies.
Feasibility and Effect of Wrapping Nerves With a Multi-Layer Perinatal Tissue Allograft During Prostatectomy
Sponsor: Mayo Clinic
Summary
This clinical trial studies whether a new multi-layer perinatal tissue allograft, MLG-Complete (Trademark), can be used to improve complications after nerve-sparing robot-assisted radical prostatectomy (RARP) in patients with prostate cancer that has not spread to other parts of the body (localized). Two major complications that can happen after complete surgical removal of the prostate (radical prostatectomy) include erectile dysfunction and urinary incontinence, both of which greatly affect a patient's quality of life and social well-being. The goal of nerve-sparing radical prostatectomy is to preserve erectile and urinary function, but damage to the surrounding nerves and blood vessels can still occur causing the patient to experience the complications. An allograft is the transplant of an organ, tissue, or cells from one individual to another individual of the same species who is not an identical twin. The MLG-Complete allograft is made up of perinatal tissue and is placed on the nerve bundles during a nerve-sparing RARP. It is meant to serve as a barrier and provide coverage to the nerve bundles from the surrounding environment, which may improve post-nerve-sparing RARP complications.
Official title: RAP: Prospective Pragmatic Multi-Site Trial Evaluating the Feasibility and Effect of Wrapping the Cavernous Nerves With a Novel Multi-Layer Perinatal Tissue Allograft During Prostatectomy
Key Details
Gender
MALE
Age Range
45 Years - Any
Study Type
INTERVENTIONAL
Enrollment
25
Start Date
2025-08-14
Completion Date
2030-07-30
Last Updated
2025-11-10
Healthy Volunteers
No
Conditions
Interventions
Allografting
Undergo placement of MLG-Complete allograft
Survey Administration
Ancillary studies
Locations (1)
Mayo Clinic in Florida
Jacksonville, Florida, United States