Pudendal NerveNCT01832168
Randomized Clinical Trial Using Amniotic Membrane in Robotic Assisted Laparoscopic Prostatectomy
A study testing Robotic Assisted Laparoscopic Prostatectomy, Application of Absorbable Hemostat and Application of dehydrated human amniotic membrane in people with Pudendal Nerve, run by MiMedx Group, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 45 to 70 years, men only
- Conditions the study is for
- Pudendal Nerve
- What is being tested?
- Robotic Assisted Laparoscopic Prostatectomy, Application of Absorbable Hemostat and Application of dehydrated human amniotic membrane
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 45-70
- Clinically localized prostate cancer with Gleason score 6 or 7
- SHIM Score greater than or equal to 16 in the absence of medication
- Feasibility to perform unilateral or bilateral nerve sparing RALP
Who cannot join
- Clinically locally advanced cancer and/or with Gleason score 8 or 9.
- Difficulty performing nerve sparing RALP.
- Prior surgery at the site.
- Site exhibits clinical signs and symptoms of infection.
- SHIM score at screening <16.
- Current use of anticoagulant medication including Coumadin, Plavix, etc.
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- Has had "salvage prostatectomy" - patients who failed prior therapies including external radiation therapy, cryotherapy, etc.
- Has prior radiation therapy treatment at the site.
- Prior hormonal therapy such as Lupron or oral anti-androgens.
- Non-mobile, i.e. not ambulatory or bed ridden.
- The presence of comorbidities that can be confused with or can exacerbate the condition including:
- diabetes
- advanced atherosclerotic vascular disease
- 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 on any investigational drug(s) or therapeutic device(s) within 30 days preceding screening.
- Unable to comply with penile rehabilitation.
- Known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.
- Patients who are unable to understand the aims and objectives of the trial.
- 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.
- Currently taking medications which could affect graft incorporation (supervising physician's discretion).
- Allergic to gentamicin and/or streptomycin.
- Damage to neurovascular bundles during surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
Jackson South Urology Center of Excellence
Miami, Florida, 33176
About this study
Official title: A Prospective Randomized Clinical Trial Using Amniotic Membrane in Robotic Assisted Laparoscopic Prostatectomy (RALP)- Effect on Nerve Protection.
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
- Pudendal Nerve
- Being tested
- Robotic Assisted Laparoscopic Prostatectomy, Application of Absorbable Hemostat, Application of dehydrated human amniotic membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Assisted Laparoscopic ProstatectomyProcedure or surgery
Robotic Assisted Laparoscopic Prostatectomy with nerve-sparing technique
Application of Absorbable HemostatOther
Also called Surgicel® SNoW
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 membraneOther
Also called AmnioFix
Application of dehydrated human amniotic membrane (DHAM) on the neurovascular bundle after removal of the cancerous prostate.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Robotic Assisted Laparoscopic Prostatectomy with application of absorbable hemostat. Receives: Procedure: Robotic Assisted Laparoscopic Prostatectomy; Other: Application of Absorbable Hemostat |
| AmnioFix | Experimental | Robotic Assisted Laparoscopic Prostatectomy with application of dehydrated human amniotic membrane. Receives: Procedure: Robotic Assisted Laparoscopic Prostatectomy; Other: Application of dehydrated human amniotic membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients achieving return to baseline Sexual Health Inventory for Men (SHIM) score in the AmnioFix group versus the Control group.
Measured: 4 weeks
Secondary outcomes (2)
Time to return of erectile function.
Measured: Up to 6 months
Pain scores.
Measured: 10 days, 4 weeks, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pudendal NerveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- MiMedx Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sanjay Razdan, MD, Principal investigator, Jackson South Urology Center of Excellence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01832168
- Sponsor's protocol ID
- AFRALP001
- Status last verified
- Mar 2015
- First submitted
- 11 Apr 2013
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Clinical Trial Using Amniotic Membrane in Robotic Assisted Laparoscopic Prostatectomy (RALP)- Effect on Nerve Protection.
- ClinicalTrials.gov ID
- NCT01832168
- Acronym / sponsor ID
- AFRALP001
- Conditions
- Pudendal Nerve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- MiMedx Group, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 15 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Procedure: Robotic Assisted Laparoscopic Prostatectomy, Other: Application of Absorbable HemostatRobotic Assisted Laparoscopic Prostatectomy with application of absorbable hemostat. |
| AmnioFix | Experimental | Procedure: Robotic Assisted Laparoscopic Prostatectomy, Other: Application of dehydrated human amniotic membraneRobotic Assisted Laparoscopic Prostatectomy with application of dehydrated human amniotic membrane. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ages 45-70
- Clinically localized prostate cancer with Gleason score 6 or 7
- SHIM Score greater than or equal to 16 in the absence of medication
- Feasibility to perform unilateral or bilateral nerve sparing RALP
Key exclusion criteria (22 listed)
- Clinically locally advanced cancer and/or with Gleason score 8 or 9.
- Difficulty performing nerve sparing RALP.
- Prior surgery at the site.
- Site exhibits clinical signs and symptoms of infection.
- SHIM score at screening <16.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic Assisted Laparoscopic ProstatectomyRobotic Assisted Laparoscopic Prostatectomy with nerve-sparing technique | Procedure or surgery | AmnioFix, Control |
| Application of Absorbable HemostatAlso: Surgicel® SNoWApplication of Surgicel® SNoW Absorbable Hemostat by Johnson and Johnson on the neurovascular bundle after removal of the cancerous prostate. | Other | Control |
| Application of dehydrated human amniotic membraneAlso: AmnioFixApplication of dehydrated human amniotic membrane (DHAM) on the neurovascular bundle after removal of the cancerous prostate. | Other | AmnioFix |
Primary outcome
The proportion of patients achieving return to baseline Sexual Health Inventory for Men (SHIM) score in the AmnioFix group versus the Control group.
Time frame: 4 weeks
2 secondary outcomes
Time to return of erectile function.
Time frame: Up to 6 months
Pain scores.
Time frame: 10 days, 4 weeks, 3 months, and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanjay Razdan, MD principal investigator
Jackson South Urology Center of Excellence
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic Assisted Laparoscopic Prostatectomy, Application of Absorbable Hemostat and Application of dehydrated human amniotic membrane in people with Pudendal Nerve, run by MiMedx Group, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients achieving return to baseline Sexual Health Inventory for Men (SHIM) score in the AmnioFix group versus the Control group. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2015.