Back to resultsFeasibility Study of the Uriprene Stent Following Uncomplicated Ureteroscopy (URIPRENE)
Primary Purpose
Unilateral Ureteral Stone, Renal Stone Fragments ≤ 2mm
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Post-Ureteroscopy ADVA-Tec Uriprene™ Degradable Temporary Ureteral Stent
Sponsored by
About this trial
This is an interventional treatment trial for Unilateral Ureteral Stone focused on measuring Renal Stone, Ureteroscopy, Ureteral Stent, post-uncomplicated ureteroscopy, UURS
Eligibility Criteria
Inclusion Criteria:
- Patients who are > 18, < 80 years of age; inclusive of males and females.
- Patients with unilateral ureteral or renal stone fragments < 2mm, post-uncomplicated ureteroscopy (UURS).
- 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.
- 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:
- Patients with a known contraindication for treatment with the Uriprene® Stent.
- Patients with a history of an anatomical abnormality of the urinary tract.
- Patients with a known upper or lower urinary tract infection at the time of stent insertion.
- Patients with known renal insufficiency or chronic impairment.
- Any condition, in the opinion of the investigator, in whom patients would not be eligible for treatment with the Uriprene® Stent.
- Pregnant or lactating women, or women of childbearing potential who do not employ a reliable method of contraception as judged by the Investigator.
- Patients who consume more than 14 drinks of alcohol per week (as this may affect degradation of the stent).
- Presence of ureteral blockage or stricture
- After failed guide wire placement or failed ureteroscopic access
- Impacted ureteral stones still in place
- Patients predisposed to urinary stasis e.g. neurogenic bladder, bladder outlet obstruction, known pregnancy
- Patients with a solitary kidney
- Presence of ureteral fistula
- Presence of ureteral tumor
- Presence of extrinsic compression of the ureter
- Urinary tract infection
- Staghorn calculi
Sites / Locations
- University of British Columbia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Interventional
Arm Description
Placement of ureteral stent following post-ureteroscopy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Technical Success
Technical success of the device defined as complete degradation of the stent within 90 days, as measured by radiology
Pain
Degree of comfort and pain as measured by the Pain, Symptom, and Satisfaction Questionnaire
Full Information
NCT ID
NCT02032316
First Posted
January 8, 2014
Last Updated
January 13, 2015
Sponsor
Adva-Tec
Collaborators
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT02032316
Brief Title
Feasibility Study of the Uriprene Stent Following Uncomplicated Ureteroscopy
Acronym
URIPRENE
Official Title
URIPRENE: Feasibility Study to Evaluate the Preliminary Safety and Effectiveness of the Uriprene Stent Following Uncomplicated Ureteroscopy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Adva-Tec
Collaborators
University of British Columbia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unilateral Ureteral Stone, Renal Stone Fragments ≤ 2mm
Keywords
Renal Stone, Ureteroscopy, Ureteral Stent, post-uncomplicated ureteroscopy, UURS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interventional
Arm Type
Experimental
Arm Description
Placement of ureteral stent following post-ureteroscopy
Intervention Type
Device
Intervention Name(s)
Post-Ureteroscopy ADVA-Tec Uriprene™ Degradable Temporary Ureteral Stent
Other Intervention Name(s)
Renal ureteral stent
Intervention Description
Renal stent placed after uncomplicated uteroscopy
Primary Outcome Measure Information:
Title
Safety
Description
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.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Technical Success
Description
Technical success of the device defined as complete degradation of the stent within 90 days, as measured by radiology
Time Frame
90 days
Title
Pain
Description
Degree of comfort and pain as measured by the Pain, Symptom, and Satisfaction Questionnaire
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who are > 18, < 80 years of age; inclusive of males and females.
Patients with unilateral ureteral or renal stone fragments < 2mm, post-uncomplicated ureteroscopy (UURS).
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.
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:
Patients with a known contraindication for treatment with the Uriprene® Stent.
Patients with a history of an anatomical abnormality of the urinary tract.
Patients with a known upper or lower urinary tract infection at the time of stent insertion.
Patients with known renal insufficiency or chronic impairment.
Any condition, in the opinion of the investigator, in whom patients would not be eligible for treatment with the Uriprene® Stent.
Pregnant or lactating women, or women of childbearing potential who do not employ a reliable method of contraception as judged by the Investigator.
Patients who consume more than 14 drinks of alcohol per week (as this may affect degradation of the stent).
Presence of ureteral blockage or stricture
After failed guide wire placement or failed ureteroscopic access
Impacted ureteral stones still in place
Patients predisposed to urinary stasis e.g. neurogenic bladder, bladder outlet obstruction, known pregnancy
Patients with a solitary kidney
Presence of ureteral fistula
Presence of ureteral tumor
Presence of extrinsic compression of the ureter
Urinary tract infection
Staghorn calculi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ben Chew, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Feasibility Study of the Uriprene Stent Following Uncomplicated Ureteroscopy
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