Unilateral Ureteral StonePhase 1URIPRENENCT02032316
Feasibility Study of the Uriprene Stent Following Uncomplicated Ureteroscopy
A Phase 1 study testing Post-Ureteroscopy ADVA-Tec Uriprene™ Degradable Temporary Ureteral Stent in people with Unilateral Ureteral Stone and Renal Stone Fragments ≤ 2mm, run by Adva-Tec at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Unilateral Ureteral Stone, Renal Stone Fragments ≤ 2mm
- What is being tested?
- Post-Ureteroscopy ADVA-Tec Uriprene™ Degradable Temporary Ureteral Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2014to Dec 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Being tested
- Post-Ureteroscopy ADVA-Tec Uriprene™ Degradable Temporary Ureteral Stent
- Keywords
- Renal Stone, Ureteroscopy, Ureteral Stent, post-uncomplicated ureteroscopy, UURS
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-Ureteroscopy ADVA-Tec Uriprene™ Degradable Temporary Ureteral StentDevice
Also called Renal ureteral stent
Renal stent placed after uncomplicated uteroscopy
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Placement of ureteral stent following post-ureteroscopy Receives: Device: Post-Ureteroscopy ADVA-Tec Uriprene™ Degradable Temporary Ureteral Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (2)
Technical Success
Technical success of the device defined as complete degradation of the stent within 90 days, as measured by radiology
Measured: 90 days
Pain
Degree of comfort and pain as measured by the Pain, Symptom, and Satisfaction Questionnaire
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Ureteral StoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adva-Tec
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of British Columbia
- Responsible party
- Sponsor
- Investigators
- Ben Chew, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02032316
- Sponsor's protocol ID
- CLIN 14-32-002
- Acronym
- URIPRENE
- Status last verified
- Jan 2015
- First submitted
- 8 Jan 2014
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- URIPRENE: Feasibility Study to Evaluate the Preliminary Safety and Effectiveness of the Uriprene Stent Following Uncomplicated Ureteroscopy
- ClinicalTrials.gov ID
- NCT02032316
- Acronym / sponsor ID
- URIPRENE / CLIN 14-32-002
- Keywords
- Renal Stone, Ureteroscopy, Ureteral Stent, post-uncomplicated ureteroscopy, UURS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Adva-TecIndustry (pharma, biotech, devices)
- Collaborators
- University of British Columbia
- Study start
- Mar 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 10 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Device: Post-Ureteroscopy ADVA-Tec Uriprene™ Degradable Temporary Ureteral StentPlacement of ureteral stent following post-ureteroscopy |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Post-Ureteroscopy ADVA-Tec Uriprene™ Degradable Temporary Ureteral StentAlso: Renal ureteral stentRenal stent placed after uncomplicated uteroscopy | Device | Interventional |
Primary outcome
Safety
Time frame: 90 days
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.
2 secondary outcomes
Technical Success
Time frame: 90 days
Pain
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2015.
Related trials for Unilateral Ureteral Stone
Recruiting
Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative
Stone, Kidney, Stone Ureter
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ben Chew, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Post-Ureteroscopy ADVA-Tec Uriprene™ Degradable Temporary Ureteral Stent in people with Unilateral Ureteral Stone and Renal Stone Fragments ≤ 2mm, run by Adva-Tec at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2015.