Clinical trial NCT02032316: Feasibility Study of the Uriprene Stent Following Uncomplicated Ureteroscopy
Official title: URIPRENE: Feasibility Study to Evaluate the Preliminary Safety and Effectiveness of the Uriprene Stent Following Uncomplicated Ureteroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Unilateral Ureteral Stone
Renal Stone Fragments ≤ 2mm
Keywords: Renal Stone
Ureteroscopy
Ureteral Stent
post-uncomplicated ureteroscopy
UURS
Lead sponsor: Adva-Tec
Sponsor class: INDUSTRY
Collaborators: name: University of British Columbia
First posted: 2014-01-10
Enrollment: 8
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Primary Objective: To assess the safety and feasibility of the Uriprene® Stent by assessing the time to complete degradation or the passage of stent fragments from the bladder by radiological assessment.

Subject Population: Patients with clinical symptoms consistent with unilateral ureteral or renal stone fragments ≤ 2mm, post-uncomplicated ureteroscopy (UURS).

Eligibility criteria: 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

Primary outcomes:
measure: Safety
timeFrame: 90 days
Secondary outcomes:
measure: Technical Success
timeFrame: 90 days
measure: Pain
timeFrame: 90 days
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Ben Chew, MD
role: PRINCIPAL_INVESTIGATOR
References: