NCT02526173

Brief Summary

The investigators will examine the beneficial impacts of applying of dHACM on the preserved neurovascular bundles (cavernosal nerves) and the prostate bed during robotic assisted laparoscopic prostatectomy. Such application can result in promotion of soft tissue healing and reduction of inflammation at the operative site and thus an acceleration of return of potency regulating cavernosal nerves.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 18, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2018

Completed
Last Updated

September 28, 2018

Status Verified

September 1, 2018

Enrollment Period

2.7 years

First QC Date

August 13, 2015

Last Update Submit

September 27, 2018

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (2)

  • Potency as assessed by Sexual Health Inventory for Men (SHIM) Score

    As measured by SHIM

    12 months

  • Return to sexual function

    Patient directed questionnaire

    12 months

Secondary Outcomes (2)

  • Continence

    12 months

  • Continence

    12 months

Study Arms (2)

dHACM

EXPERIMENTAL

This group will receive RALP using full nerve sparing technique plus dHACM application.

Procedure: RALP using full nerve sparing techniqueOther: dHACM Application

Control

OTHER

This group will receive RALP using full nerve sparing technique only.

Procedure: RALP using full nerve sparing technique

Interventions

RALP using full nerve sparing techniquePROCEDURE

RALP using full nerve sparing technique

ControldHACM
dHACM ApplicationOTHER

2x12 sheet of dHACM applied to the neurovascular bundle

Also known as: HCT/P Part 361
dHACM

Eligibility Criteria

Age40 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male subjects between the ages 40-70.
  • Primary diagnosis of prostate cancer requiring surgical intervention
  • Have a willingness to comply with follow-up examination
  • Have ability to provide full written consent
  • Primary diagnosis of untreated with clinically localized prostate cancer with Gleason score of 6, 7,8 or 9
  • Planned elective radical prostatectomy with bilateral full nerve sparing technique
  • Patients who currently have a pre-operative SHIM \> 19
  • Negative urinalysis within 7 days prior to date of surgery

You may not qualify if:

  • Has signs or symptoms of any other disease which could result in allograft failure, or has experienced graft failure in the past
  • 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
  • Has comorbid conditions that can be confused with or can exacerbate the condition, including diabetes or Advanced atherosclerotic vascular disease
  • Is unable to sign or understand informed consent
  • Is unable to comply with penile rehabilitation, including oral 5-phosphodiesterase inhibitor
  • Has a history of drug or alcohol abuse within last 12 months
  • Has autoimmune disease or a known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV
  • Is allergic to Aminoglycoside antibiotics (such as Gentamicin and/or Streptomycin)
  • 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
  • Patients currently enrolled in another study. Concurrent enrollment in another study is prohibited
  • Has had prior hormonal therapy such as Lupron or oral anti-androgens
  • Living outside of United States
  • Partial nerve sparing technique used during Radical Prostatectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida Hospital: Global Robotics Institute

Celebration, Florida, 34747, United States

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Officials

  • Vipul Patel, MD

    MiMedx Group, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2015

First Posted

August 18, 2015

Study Start

October 1, 2015

Primary Completion

June 21, 2018

Study Completion

June 21, 2018

Last Updated

September 28, 2018

Record last verified: 2018-09

Locations

US(1)