Peripheral Nerve InjuryPhase 4NCT00953277
Study of Nerve Reconstruction Using AVANCE in Subjects Who Undergo Robotic Assisted Prostatectomy for Treatment of Prostate Cancer
A Phase 4 study testing Processed Human Nerve Tissue Scaffold in people with Peripheral Nerve Injury and Prostate Cancer, run by Axogen Corporation at 1 site in United States.
Trial summary
The purpose of this study is to determine if it is technically feasable to repair nerves that are injured as part of a planned surgical removal of the prostate and the surrounding tissue in subjects with prostate cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Peripheral Nerve Injury, Prostate Cancer, Radical Prostatectomy
- What is being tested?
- Processed Human Nerve Tissue Scaffold
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Apr 2015
- Phase
- Phase 4
- 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 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age, but ≤70 years of age;
- IIEF EF Domain*1 score ≥ 22;
- be able to effectively communicate with study personnel;
- be considered by the physician to be available for subsequent visits;
- be willing to comply with all aspects of the treatment and evaluation schedule over a 24 month duration;
- sign and date an IRB-approved written informed consent prior to initiation of any study procedures, including screening procedures; and
- require radical prostatectomy.
Who cannot join
- prior surgery in the last 6 months which could affect sexual function;
- history of Peyronie's disease;
- significant neurological disorder (i.e. multiple sclerosis, peripheral neuropathy);
- treatment for major psychiatric disorders;
- history of penile implant or prosthesis;
- history of diabetic neuropathy;
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- life expectancy of less than two years;
- concurrently involved in another investigational study;
- uncontrolled hypertension with systolic BP >200mmHg or diastolic BP >115mmHg is present at screening;
- currently receiving or planned treatment with chemotherapy or radiation therapy;
- diagnosis of bony metastasis;
- known allergy or severe intolerance to PDE-5 inhibitors; or
- cardiac pacing equipment or other electro-mechanical devices which preclude the use of CaverMap™ neurostimulator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Assess the Technical Feasibility of Robotic Assisted Laparoscopic Interpositioning of the AVANCETM Nerve Graft for Reconstruction of the Neurovascular Bundle, With a Twenty-four Month Follow-up Term to Assess Efficacy
The purpose of this study is to determine if it is technically feasable to repair nerves that are injured as part of a planned surgical removal of the prostate and the surrounding tissue in subjects with prostate cancer. The study will also examine the long term outcomes on erectile function, continence and overall quality of life in the enrolled subjects.
- Conditions
- Peripheral Nerve Injury, Prostate Cancer, Radical Prostatectomy, Nerve Reconstruction, Cavernous Nerve Injury
- Being tested
- Processed Human Nerve Tissue Scaffold
- Keywords
- Nerve Repair, Erectile Function, Prostate Cancer, Robot Assisted Laparoscopic Prostatectomy, Continence
- Medical subject headings
- Peripheral Nerve Injuries, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Processed Human Nerve Tissue ScaffoldOther
Implantation of appropriate length of processed human nerve scaffold at the time of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Avance Nerve Graft | Experimental | Processed Human Nerve Tissue Scaffold Receives: Other: Processed Human Nerve Tissue Scaffold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgeon Assessment of Technical Feasibility
Measured: At time of surgery
Secondary outcomes (4)
Erectile Recovery Rates
Measured: Month 1, 3, 6, 9, 12, 18 and 24
Continence Rates
Measured: Month 1, 3, 6, 9, 12, 18 and 24
Quality of Life Questionnaire
Measured: Month 1, 3, 6, 9, 12, 18 and 24
Adverse Events
Measured: Month 1, 3, 6, 9, 12, 18 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nerve InjuryStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Axogen Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph J Smith, MD, Principal investigator, Vanderbilt Univerisity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00953277
- Sponsor's protocol ID
- ANG-CP-003
- Status last verified
- Aug 2024
- First submitted
- 4 Aug 2009
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Technical Feasibility of Robotic Assisted Laparoscopic Interpositioning of the AVANCETM Nerve Graft for Reconstruction of the Neurovascular Bundle, With a Twenty-four Month Follow-up Term to Assess Efficacy
- ClinicalTrials.gov ID
- NCT00953277
- Acronym / sponsor ID
- ANG-CP-003
- Conditions
- Peripheral Nerve Injury, Prostate Cancer, Radical Prostatectomy, Nerve Reconstruction, Cavernous Nerve Injury
- Keywords
- Nerve Repair, Erectile Function, Prostate Cancer, Robot Assisted Laparoscopic Prostatectomy, Continence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Axogen CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 6 Aug 2009 (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 if it is technically feasable to repair nerves that are injured as part of a planned surgical removal of the prostate and the surrounding tissue in subjects with prostate cancer. The study will also examine the long term outcomes on erectile function, continence and overall quality of life in the enrolled subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Avance Nerve Graft | Experimental | Other: Processed Human Nerve Tissue ScaffoldProcessed Human Nerve Tissue Scaffold |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥ 18 years of age, but ≤70 years of age;
- IIEF EF Domain*1 score ≥ 22;
- be able to effectively communicate with study personnel;
- be considered by the physician to be available for subsequent visits;
- be willing to comply with all aspects of the treatment and evaluation schedule over a 24 month duration;
Key exclusion criteria (13 listed)
- prior surgery in the last 6 months which could affect sexual function;
- history of Peyronie's disease;
- significant neurological disorder (i.e. multiple sclerosis, peripheral neuropathy);
- treatment for major psychiatric disorders;
- history of penile implant or prosthesis;
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 |
|---|---|---|
| Processed Human Nerve Tissue ScaffoldImplantation of appropriate length of processed human nerve scaffold at the time of surgery. | Other | Avance Nerve Graft |
Primary outcome
Surgeon Assessment of Technical Feasibility
Time frame: At time of surgery
4 secondary outcomes
Erectile Recovery Rates
Time frame: Month 1, 3, 6, 9, 12, 18 and 24
Continence Rates
Time frame: Month 1, 3, 6, 9, 12, 18 and 24
Quality of Life Questionnaire
Time frame: Month 1, 3, 6, 9, 12, 18 and 24
Adverse Events
Time frame: Month 1, 3, 6, 9, 12, 18 and 24
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 12 Aug 2024.
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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.
Joseph J Smith, MD principal investigator
Vanderbilt Univerisity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Processed Human Nerve Tissue Scaffold in people with Peripheral Nerve Injury and Prostate Cancer, run by Axogen Corporation 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 7 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 12 Aug 2024. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Surgeon Assessment of Technical Feasibility (time frame: At time of surgery). 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 12 Aug 2024.