Feasibility and Effect of Wrapping Nerves With a Multi-Layer Perinatal Tissue Allograft During Prostatectomy

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Mayo Clinic
Study ID
NCT06940271
Status
Recruiting
Apply to this trial

Conditions

  • Localized Prostate Carcinoma
  • Stage I Prostate Cancer AJCC v8
  • Stage II Prostate Cancer AJCC v8
  • Stage III Prostate Cancer AJCC v8

Eligibility Criteria

Sex
MALE
Age
45 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Allografting — PROCEDURE
    Undergo placement of MLG-Complete allograft
  • Survey Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Aug 14, 2025
Status verified
Nov 2025
Primary completion
Jul 30, 2030
Completion
Jul 30, 2030

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Supportive care (MLG-Complete allograft)
    Patients undergo placement of MLG-Complete allograft to nerve bundles over 5 minutes during standard of care nerve-sparing RARP.

Primary Outcome Measure

Ability to place MLG-Complete allograft without lengthening operative time (Feasibility) [ Time Frame: Baseline [time of robot-assisted radical prostatectomy (RARP)] ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980
Clinical Trials Referral Office
[email protected]
855-776-0015
Ram Pathak, MD (PRINCIPAL_INVESTIGATOR)

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Mayo Clinic in Florida· Jacksonville, FL

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