Renal Stone Fragments = 2mm Clinical Trial
— URIPRENEOfficial title:
URIPRENE: Feasibility Study to Evaluate the Preliminary Safety and Effectiveness of the Uriprene Stent Following Uncomplicated Ureteroscopy
| Verified date | January 2015 |
| Source | Adva-Tec |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Health Canada |
| Study type | Interventional |
A prospective, single-center, single-arm, trial to demonstrate safety and device performance of the ADVA-Tec Uriprene™ Degradable Temporary Ureteral Stent. This is a first-in-man clinical study in a small human population.
| Status | Completed |
| Enrollment | 8 |
| Est. completion date | December 2014 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 19 Years to 79 Years |
| Eligibility |
Inclusion Criteria: 1. Patients who are > 18, < 80 years of age; inclusive of males and females. 2. Patients with unilateral ureteral or renal stone fragments < 2mm, post-uncomplicated ureteroscopy (UURS). 3. Patients with a height and body size able to accommodate a 20, 22, 24, 26, 28, or 30 mm long ureteral stent, as judged by the Investigator. 4. Patients with the ability to understand the requirements of the study, who have provided written informed consent, and who have agreed to return for the required follow-up assessments. Exclusion Criteria: 1. Patients with a known contraindication for treatment with the Uriprene® Stent. 2. Patients with a history of an anatomical abnormality of the urinary tract. 3. Patients with a known upper or lower urinary tract infection at the time of stent insertion. 4. Patients with known renal insufficiency or chronic impairment. 5. Any condition, in the opinion of the investigator, in whom patients would not be eligible for treatment with the Uriprene® Stent. 6. Pregnant or lactating women, or women of childbearing potential who do not employ a reliable method of contraception as judged by the Investigator. 7. Patients who consume more than 14 drinks of alcohol per week (as this may affect degradation of the stent). 8. Presence of ureteral blockage or stricture 9. After failed guide wire placement or failed ureteroscopic access 10. Impacted ureteral stones still in place 11. Patients predisposed to urinary stasis e.g. neurogenic bladder, bladder outlet obstruction, known pregnancy 12. Patients with a solitary kidney 13. Presence of ureteral fistula 14. Presence of ureteral tumor 15. Presence of extrinsic compression of the ureter 16. Urinary tract infection 17. Staghorn calculi |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | University of British Columbia | Vancouver | British Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Adva-Tec | University of British Columbia |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety | Composite of new-onset serious adverse event(s) including death, infection, the occurrence of surgery, re-hospitalization and or repeat hospitalization related to the device, or device related injury of the ureter. | 90 days | Yes |
| Secondary | Technical Success | Technical success of the device defined as complete degradation of the stent within 90 days, as measured by radiology | 90 days | No |
| Secondary | Pain | Degree of comfort and pain as measured by the Pain, Symptom, and Satisfaction Questionnaire | 90 days | No |