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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avance Nerve Graft | Experimental | Processed Human Nerve Tissue Scaffold |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Processed Human Nerve Tissue Scaffold | Other | Implantation of appropriate length of processed human nerve scaffold at the time of surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Surgeon Assessment of Technical Feasibility | At time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Erectile Recovery Rates | Month 1, 3, 6, 9, 12, 18 and 24 | |
| Continence Rates | Month 1, 3, 6, 9, 12, 18 and 24 | |
| Quality of Life Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph J Smith, MD | Vanderbilt Univerisity | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
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| Month 1, 3, 6, 9, 12, 18 and 24 |
| Adverse Events | Month 1, 3, 6, 9, 12, 18 and 24 |
| ID | Term |
|---|---|
| D059348 | Peripheral Nerve Injuries |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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