Erectile DysfunctionNCT02526173
DHACM in Robotic Assisted Laparoscopic Prostatectomy (RALP)
A study testing RALP using full nerve sparing technique and dHACM Application in people with Erectile Dysfunction, run by MiMedx Group, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- RALP using full nerve sparing technique and dHACM Application
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2015to 21 Jun 2018
- 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 40 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida Hospital: Global Robotics Institute
Celebration, Florida, 34747
About this study
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
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.
Read the 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)
- Conditions
- Erectile Dysfunction
- Being tested
- RALP using full nerve sparing technique, dHACM Application
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RALP using full nerve sparing techniqueProcedure or surgery
RALP using full nerve sparing technique
dHACM ApplicationOther
Also called HCT/P Part 361
2x12 sheet of dHACM applied to the neurovascular bundle
| Study group | Role | What they receive |
|---|---|---|
| dHACM | Experimental | This group will receive RALP using full nerve sparing technique plus dHACM application. Receives: Procedure: RALP using full nerve sparing technique; Other: dHACM Application |
| Control | Other | This group will receive RALP using full nerve sparing technique only. Receives: Procedure: RALP using full nerve sparing technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Potency as assessed by Sexual Health Inventory for Men (SHIM) Score
As measured by SHIM
Measured: 12 months
Return to sexual function
Patient directed questionnaire
Measured: 12 months
Secondary outcomes (2)
Continence
As assessed by American Urological Association (AUA) score
Measured: 12 months
Continence
Patient directed questionnaire
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study start1 Oct 2015
- Primary completion21 Jun 2018
- Study completion21 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- MiMedx Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vipul Patel, MD, Principal investigator, MiMedx Group, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02526173
- Sponsor's protocol ID
- AFRLP003
- Status last verified
- Sep 2018
- First submitted
- 13 Aug 2015
- Last updated
- 28 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02526173
- Acronym / sponsor ID
- AFRLP003
- Conditions
- Erectile Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- MiMedx Group, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 21 Jun 2018 (actual)
- Study completion
- 21 Jun 2018 (actual)
- First posted
- 18 Aug 2015 (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 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dHACM | Experimental | Procedure: RALP using full nerve sparing technique, Other: dHACM ApplicationThis group will receive RALP using full nerve sparing technique plus dHACM application. |
| Control | Other | Procedure: RALP using full nerve sparing techniqueThis group will receive RALP using full nerve sparing technique only. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
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 |
|---|---|---|
| RALP using full nerve sparing techniqueRALP using full nerve sparing technique | Procedure or surgery | Control, dHACM |
| dHACM ApplicationAlso: HCT/P Part 3612x12 sheet of dHACM applied to the neurovascular bundle | Other | dHACM |
Primary outcome
Potency as assessed by Sexual Health Inventory for Men (SHIM) Score
Time frame: 12 months
As measured by SHIM
Return to sexual function
Time frame: 12 months
Patient directed questionnaire
2 secondary outcomes
Continence
Time frame: 12 months
Continence
Time frame: 12 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 28 Sep 2018.
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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.
Vipul Patel, MD principal investigator
MiMedx Group, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RALP using full nerve sparing technique and dHACM Application in people with Erectile Dysfunction, 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 8 inclusion and 13 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 28 Sep 2018. 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?
Potency as assessed by Sexual Health Inventory for Men (SHIM) Score (time frame: 12 months). The study lists 2 primary outcomes in all. 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 28 Sep 2018.