Back to results

DHACM in Robotic Assisted Laparoscopic Prostatectomy (RALP)

Primary Purpose

Erectile Dysfunction

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

RALP using full nerve sparing technique

dHACM Application

About this trial

This is an interventional treatment trial for Erectile Dysfunction

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Florida Hospital: Global Robotics Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

dHACM

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

As measured by SHIM

Return to sexual function

Patient directed questionnaire

Secondary Outcome Measures

Continence

As assessed by American Urological Association (AUA) score

Continence

Patient directed questionnaire

Full Information

NCT ID

NCT02526173

First Posted

August 13, 2015

Last Updated

September 27, 2018

Sponsor

MiMedx Group, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02526173

Brief Title

DHACM in Robotic Assisted Laparoscopic Prostatectomy (RALP)

Official Title

A Prospective Randomized Clinical Trial Using Dehydrated Human Amnion/Chorion Membrane (dHACM) in Nerve Sparing Robotic Assisted Laparoscopic Radical Prostatectomy (RALP) - Effect on Potency Outcomes

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

October 1, 2015 (Actual)

Primary Completion Date

June 21, 2018 (Actual)

Study Completion Date

June 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MiMedx Group, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

The overall objective of this study is to evaluate the effectiveness of dehydrated human amnion/chorion membrane (dHACM) in reducing neurovascular bundle inflammation in prostate cancer patients undergoing bilateral full nerve sparing robotic assisted laparoscopic radical prostatectomy (RALP). Specifically, this study compares potency outcomes in patients who had full nerve sparing RALP procedures with dHACM application to the neurovascular bundles to that of full nerve sparing RALP without dHACM application to neurovascular bundles. Patients will be randomized to one of two possible treatment groups: Group 1 - Treatment Group ( Full Nerve Sparing RALP + AmnioFix®) Group 2 - Control Group ( Full Nerve Sparing RALP alone)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Erectile Dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

230 (Actual)

8. Arms, Groups, and Interventions

Arm Title

dHACM

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

Other

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

RALP using full nerve sparing technique

Intervention Description

RALP using full nerve sparing technique

Intervention Type

Other

Intervention Name(s)

dHACM Application

Other Intervention Name(s)

HCT/P Part 361

Intervention Description

2x12 sheet of dHACM applied to the neurovascular bundle

Primary Outcome Measure Information:

Title

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

Description

As measured by SHIM

Time Frame

12 months

Title

Return to sexual function

Description

Patient directed questionnaire

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Continence

Description

As assessed by American Urological Association (AUA) score

Time Frame

12 months

Title

Continence

Description

Patient directed questionnaire

Time Frame

12 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vipul Patel, MD

Organizational Affiliation

MiMedx Group, Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Florida Hospital: Global Robotics Institute

City

Celebration

State/Province

Florida

ZIP/Postal Code

34747

Country

United States

12. IPD Sharing Statement

Learn more about this trial

DHACM in Robotic Assisted Laparoscopic Prostatectomy (RALP)

We'll reach out to this number within 24 hrs