A Phase 4 interventional study of Processed Human Nerve Tissue Scaffold in Peripheral Nerve Injury, Prostate Cancer and Radical Prostatectomy, sponsored by Axogen Corporation. Completed at 1 site in United States. Open to male participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-08-12.
Sponsored by Axogen Corporation · Phase 4, Interventional, and Treatment
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 12 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Axogen Corporation is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Processed Human Nerve Tissue Scaffold
Other: Processed Human Nerve Tissue Scaffold
Implantation of appropriate length of processed human nerve scaffold at the time of surgery.
Surgeon Assessment of Technical Feasibility
Time frame: At time of surgery
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
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Axogen Corporation