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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01832168
Other study ID # AFRALP001
Secondary ID
Status Completed
Phase N/A
First received April 11, 2013
Last updated March 16, 2015
Start date February 2013
Est. completion date June 2014

Study information

Verified date March 2015
Source MiMedx Group, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether the AmnioFix dehydrated human amniotic membrane is effective in protecting nerves in men receiving robotic assisted laparoscopic prostatectomies.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Male
Age group 45 Years to 70 Years
Eligibility Inclusion Criteria:

1. Ages 45-70

2. Clinically localized prostate cancer with Gleason score 6 or 7

3. SHIM Score greater than or equal to 16 in the absence of medication

4. Feasibility to perform unilateral or bilateral nerve sparing RALP

Exclusion Criteria:

1. Clinically locally advanced cancer and/or with Gleason score 8 or 9.

2. Difficulty performing nerve sparing RALP.

3. Prior surgery at the site.

4. Site exhibits clinical signs and symptoms of infection.

5. SHIM score at screening <16.

6. Current use of anticoagulant medication including Coumadin, Plavix, etc.

7. Has had "salvage prostatectomy" - patients who failed prior therapies including external radiation therapy, cryotherapy, etc.

8. Has prior radiation therapy treatment at the site.

9. Prior hormonal therapy such as Lupron or oral anti-androgens.

10. Non-mobile, i.e. not ambulatory or bed ridden.

11. The presence of comorbidities that can be confused with or can exacerbate the condition including:

1. diabetes

2. advanced atherosclerotic vascular disease

12. 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.

13. Patients on any investigational drug(s) or therapeutic device(s) within 30 days preceding screening.

14. Unable to comply with penile rehabilitation.

15. Known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.

16. Patients who are unable to understand the aims and objectives of the trial.

17. Presence of any condition(s) which seriously compromises the subject's ability to complete this study, or has a known history of poor adherence with medical treatment.

18. Currently taking medications which could affect graft incorporation (supervising physician's discretion).

19. Allergic to gentamicin and/or streptomycin.

20. Damage to neurovascular bundles during surgery.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Robotic Assisted Laparoscopic Prostatectomy
Robotic Assisted Laparoscopic Prostatectomy with nerve-sparing technique
Other:
Application of Absorbable Hemostat
Application of Surgicel® SNoW Absorbable Hemostat by Johnson and Johnson on the neurovascular bundle after removal of the cancerous prostate.
Application of dehydrated human amniotic membrane
Application of dehydrated human amniotic membrane (DHAM) on the neurovascular bundle after removal of the cancerous prostate.

Locations

Country Name City State
United States Jackson South Urology Center of Excellence Miami Florida

Sponsors (1)

Lead Sponsor Collaborator
MiMedx Group, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The proportion of patients achieving return to baseline Sexual Health Inventory for Men (SHIM) score in the AmnioFix group versus the Control group. 4 weeks No
Secondary Time to return of erectile function. Up to 6 months No
Secondary Pain scores. 10 days, 4 weeks, 3 months, and 6 months No
See also
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Active, not recruiting NCT06397625 - Treatment With Peripheral Nerve Stimulation of the Pudendal Nerve in Patients With Erectile Dysfunction N/A
Recruiting NCT04288349 - IntraopeRativE Use of periNeal Block for Hemorrhoidectomy N/A