Trials / Completed
CompletedNCT01832168
Randomized Clinical Trial Using Amniotic Membrane in Robotic Assisted Laparoscopic Prostatectomy
A Prospective Randomized Clinical Trial Using Amniotic Membrane in Robotic Assisted Laparoscopic Prostatectomy (RALP)- Effect on Nerve Protection.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 34 (actual)
- Sponsor
- MiMedx Group, Inc. · Industry
- Sex
- Male
- Age
- 45 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| OTHER | Application of dehydrated human amniotic membrane | Application of dehydrated human amniotic membrane (DHAM) on the neurovascular bundle after removal of the cancerous prostate. |
Timeline
- Start date
- 2013-02-01
- Primary completion
- 2014-06-01
- Completion
- 2014-06-01
- First posted
- 2013-04-15
- Last updated
- 2015-03-17
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01832168. Inclusion in this directory is not an endorsement.