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The study described below is designed to assess the safety and device performance for the drug coated balloon (DCB) for the treatment of urethral stricture.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Up to 15 subjects will be enrolled and treated with the Urotronic drug coated balloon (DCB) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urotronic Drug Coated Balloon (DCB) | Device | The Urotronic Drug Coated Balloon (DCB) is a guidewire compatible catheter with a tapered atraumatic tip. The distal end of the catheter has an inflatable balloon coated with a proprietary coating containing the drug paclitaxel that facilitates the drug's transfer to the urethral wall upon inflation. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety- Rate of Device Related Serious Complications | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety- Change in IIEF (International Index of Erectile Function) | 90 days | |
| Efficacy- Stricture Recurrence Rate | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sean Elliott, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242 | United States | ||
| Chesapeake Urology |
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| ID | Term |
|---|---|
| D014525 | Urethral Stricture |
| ID | Term |
|---|---|
| D014524 | Urethral Obstruction |
| D014522 | Urethral Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
| Hanover |
| Maryland |
| 21076 |
| United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Metro Urology | Woodbury | Minnesota | 55125 | United States |
| Urology of Virginia | Virginia Beach | Virginia | 23462 | United States |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |