Feasibility Study of the Uriprene Stent Following Uncomplicated Ureteroscopy (URIPRENE)

URIPRENE: Feasibility Study to Evaluate the Preliminary Safety and Effectiveness of the Uriprene Stent Following Uncomplicated Ureteroscopy

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.

Study Overview

• Status: Completed
• Conditions: Unilateral Ureteral Stone; Renal Stone Fragments ≤ 2mm
• Intervention / Treatment: Device: Post-Ureteroscopy ADVA-Tec Uriprene™ Degradable Temporary Ureteral Stent

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).

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
      • University of British Columbia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 79 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Interventional; Placement of ureteral stent following post-ureteroscopy	Device: Post-Ureteroscopy ADVA-Tec Uriprene™ Degradable Temporary Ureteral Stent; Renal stent placed after uncomplicated uteroscopy; Other Names: Renal ureteral stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Success	Technical success of the device defined as complete degradation of the stent within 90 days, as measured by radiology	90 days
Pain	Degree of comfort and pain as measured by the Pain, Symptom, and Satisfaction Questionnaire	90 days

Collaborators and Investigators

• Sponsor: Adva-Tec
• Collaborators: University of British Columbia

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (ACTUAL): December 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: January 8, 2014
• First Submitted That Met QC Criteria: January 9, 2014
• First Posted (ESTIMATE): January 10, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): January 14, 2015
• Last Update Submitted That Met QC Criteria: January 13, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Ureteroscopy; Renal Stone; Ureteral Stent; post-uncomplicated ureteroscopy; UURS
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Ureteral Diseases; Urolithiasis; Urinary Calculi; Calculi; Kidney Calculi; Nephrolithiasis; Ureteral Calculi; Ureterolithiasis
• Other Study ID Numbers: CLIN 14-32-002