Ureteral DiseasesURIPRENENCT04565795
Safety and Device Performance of the Uriprene® Degradable Temporary Ureteral Stent Following Uncomplicated Ureteroscopy
A study testing Uriprene® Degradable Temporary Ureteral Stent in people with Ureteral Diseases, run by Adva-Tec at 4 sites in United States.
Trial summary
A prospective, multi-center, non-randomized trial to demonstrate safety and device performance of the ADVA-Tec Uriprene® Degradable Temporary Ureteral Stent. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Ureteral Diseases
- What is being tested?
- Uriprene® Degradable Temporary Ureteral Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jul 2022to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are >21, <80 years of age; inclusive of males and females.
- Subjects with unilateral ureteral or renal stones who have undergone a successful, uncomplicated ureteroscopy (UURS).
- Subjects with asymptomatic, contralateral renal stones in sizes <4mm WHICH ARE NOT IN THE RENAL PELVIS OR URETER and who have had uncomplicated ureteroscopy (UURS) can be included. If, during the course of treatment of the target ureter with the Uriprene stent the patient's asymptomatic stone becomes symptomatic and requires treatment, the patient can only be managed with standard of care treatment including the use of an approved ureteral stent, if necessary.
- Subjects 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.
- Subjects with the ability to understand the requirements of the study, who have provided written informed consent, and are willing to undergo all follow-up assessments according to the specified schedule.
Who cannot join
- Subjects with a history of an anatomical abnormality of the urinary tract.
- Presence of ureteral fistula.
- Presence of urothelial cancer, ureteral tumor, or renal tumor.
- Presence of extrinsic compression of the ureter.
- Presence of ureteral blockage or stricture.
- Bladder outlet obstruction or neurogenic bladder.
Show all 21Show fewer
- Subjects with known/diagnosed overactive bladder (OAB).
- Subjects with known/diagnosed urge urinary incontinence (UUI).
- Subjects with a known, active upper or lower urinary tract infection at the time of stent insertion.
- Subjects with creatinine level of ˃2.5 mg/dl.
- Pregnant or lactating women, or women of childbearing potential who do not employ a reliable method of contraception as judged by the Investigator, and/or are not willing to use reliable contraception for the duration of study participation.
- Impacted ureteral stones still in place and/or incomplete stone fragmentation.
- Ureteral perforation.
- Staghorn calculi.
- Subjects with a solitary kidney.
- History of bleeding diathesis or currently taking blood thinners such as warfarin (anti- platelet agents are allowed).
- Contrast allergy that cannot be adequately pre-treated.
- Subject has known severe psychiatric disorder, substance abuse, or other reason for being unable to follow trial follow-up instructions or unable to reliably complete patient questionnaires.
- Any condition, in the opinion of the investigator, that would deem a subject as ineligible for treatment with the Uriprene® Stent.
- Subject has a known significant concomitant illness with a life expectancy of <1 year.
- Subject is known to be currently enrolled in another investigational trial.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Bodo Knudsen, MD, (614) 293-8155, bodo.knudsen@osumc.edu
- Recruiting
University of Florida
Gainesville, Florida, 32610
Vincent Bird, MD, 352-294-5120, vincent.bird@urology.ufl.edu
- Recruiting
University of California Los Angeles
Los Angeles, California, 90404
Matthew Dunn, MD, (424) 259-7909, MDDunn@mednet.ucla.edu
- Recruiting
Mayo Clinic Arizona
Phoenix, Arizona, 85054
Mitch Humphreys, MD, (480) 342-2793, humphreys.mitchell@mayo.edu
About this study
Official title: URIPRENE: Clinical Study to Evaluate the Safety and Device Performance of the ADVA-Tec Uriprene® Degradable Temporary Ureteral Stent Following Uncomplicated Ureteroscopy
A prospective, multi-center, non-randomized trial to demonstrate safety and device performance of the ADVA-Tec Uriprene® Degradable Temporary Ureteral Stent.
Read the detailed description
A prospective, multi-center, non-randomized trial to demonstrate safety and device performance of the ADVA-Tec Uriprene® Degradable Temporary Ureteral Stent. The study is intended to assess the safety and efficacy of the Uriprene® Stent by assessing adequate intervention-free drainage during use and the time to complete degradation or the passage of stent fragments/segments from the urinary system by radiological assessment.
- Conditions
- Ureteral Diseases
- Being tested
- Uriprene® Degradable Temporary Ureteral Stent
- Keywords
- ureteral stent
- Medical subject headings
- Ureteral Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uriprene® Degradable Temporary Ureteral StentDevice
Assess adequate intervention-free drainage during use and the time to complete degradation or the passage of stent fragments/segments from the urinary system by radiological assessment.
| Study group | Role | What they receive |
|---|---|---|
| Placement of ureteral stent post ureteroscopy | Experimental | Subjects with unilateral ureteral or renal stone fragments who have undergone an uncomplicated ureteroscopy (UURS) Receives: Device: Uriprene® Degradable Temporary Ureteral Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Endpoint defined as the presence of the stent during the first 48 hours
Study Success defined as adequate short-term urine drainage, defined as the presence of the stent in the ureter and the lack of surgical or invasive intervention to treat symptoms in the stented ureter during the first 48 hours following placement.
Measured: 48 hours
Primary Safety Endpoint defined as assessment of adverse events through 90 days
Assessment of Adverse Events through the 90-day follow-up period (incidence, relationship to device and severity) compared to the historical control degradable ureteral stent and plastic ureteral stents
Measured: 90 days
Secondary outcomes (3)
Overall Clinical Success
Adequate urine drainage with no intervention and no definitely device-related serious adverse events (SAEs) throughout the 90-day follow-up period.
Measured: 90 days
Technical success of the device
Complete degradation/elimination of the stent from the urinary system within 90 days as measured by radiological assessment.
Measured: 90 days
Tolerability of device presence defined as assessment of pain via the Ureteral Stent Symptom Questionnaire (USSQ) and Patient Diary for pain medications.
Tolerability of device presence defined as assessment of pain via the Ureteral Stent Symptom Questionnaire (USSQ) and Patient Diary for pain medications.
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 posted25 Sep 2020
- Study start1 Jul 2022
- Primary completionMar 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral DiseasesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with clinical symptoms consistent with unilateral ureteral or renal stone fragments post-uncomplicated ureteroscopy (UURS).
- Masking
- None (open label)
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adva-Tec
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Northwest Clinical Research Group
- Responsible party
- Sponsor
- Investigators
- Mitchell Humphreys, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04565795
- Sponsor's protocol ID
- CLN 0001
- Acronym
- URIPRENE
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2020
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- URIPRENE: Clinical Study to Evaluate the Safety and Device Performance of the ADVA-Tec Uriprene® Degradable Temporary Ureteral Stent Following Uncomplicated Ureteroscopy
- ClinicalTrials.gov ID
- NCT04565795
- Acronym / sponsor ID
- URIPRENE / CLN 0001
- Conditions
- Ureteral Diseases
- Keywords
- ureteral stent
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Adva-TecIndustry (pharma, biotech, devices)
- Collaborators
- Northwest Clinical Research Group
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 25 Sep 2020 (actual)
- 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, multi-center, non-randomized trial to demonstrate safety and device performance of the ADVA-Tec Uriprene® Degradable Temporary Ureteral Stent.
Detailed description
A prospective, multi-center, non-randomized trial to demonstrate safety and device performance of the ADVA-Tec Uriprene® Degradable Temporary Ureteral Stent. The study is intended to assess the safety and efficacy of the Uriprene® Stent by assessing adequate intervention-free drainage during use and the time to complete degradation or the passage of stent fragments/segments from the urinary system by radiological assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with clinical symptoms consistent with unilateral ureteral or renal stone fragments post-uncomplicated ureteroscopy (UURS).
| Arm | Type | Receives |
|---|---|---|
| Placement of ureteral stent post ureteroscopy | Experimental | Device: Uriprene® Degradable Temporary Ureteral StentSubjects with unilateral ureteral or renal stone fragments who have undergone an uncomplicated ureteroscopy (UURS) |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects who are >21, <80 years of age; inclusive of males and females.
- Subjects with unilateral ureteral or renal stones who have undergone a successful, uncomplicated ureteroscopy (UURS).
- Subjects with asymptomatic, contralateral renal stones in sizes <4mm WHICH ARE NOT IN THE RENAL PELVIS OR URETER and who have had uncomplicated ureteroscopy (UURS) can be included. If, during the course of treatment of the target ureter with the Uriprene stent the patient's asymptomatic stone becomes symptomatic and requires treatment, the patient can only be managed with standard of care treatment including the use of an approved ureteral stent, if necessary.
- Subjects 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.
- Subjects with the ability to understand the requirements of the study, who have provided written informed consent, and are willing to undergo all follow-up assessments according to the specified schedule.
Key exclusion criteria (21 listed)
- Subjects with a history of an anatomical abnormality of the urinary tract.
- Presence of ureteral fistula.
- Presence of urothelial cancer, ureteral tumor, or renal tumor.
- Presence of extrinsic compression of the ureter.
- Presence of ureteral blockage or stricture.
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 |
|---|---|---|
| Uriprene® Degradable Temporary Ureteral StentAssess adequate intervention-free drainage during use and the time to complete degradation or the passage of stent fragments/segments from the urinary system by radiological assessment. | Device | Placement of ureteral stent post ureteroscopy |
Primary outcome
Primary Effectiveness Endpoint defined as the presence of the stent during the first 48 hours
Time frame: 48 hours
Study Success defined as adequate short-term urine drainage, defined as the presence of the stent in the ureter and the lack of surgical or invasive intervention to treat symptoms in the stented ureter during the first 48 hours following placement.
Primary Safety Endpoint defined as assessment of adverse events through 90 days
Time frame: 90 days
Assessment of Adverse Events through the 90-day follow-up period (incidence, relationship to device and severity) compared to the historical control degradable ureteral stent and plastic ureteral stents
3 secondary outcomes
Overall Clinical Success
Time frame: 90 days
Technical success of the device
Time frame: 90 days
Tolerability of device presence defined as assessment of pain via the Ureteral Stent Symptom Questionnaire (USSQ) and Patient Diary for pain medications.
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Ureteral Diseases
RecruitingPhase 1
FORAGER-1: A Study of Vepugratinib (LY3866288; LOXO-435) in Participants With Cancer With a Change in a Gene Called FGFR3
Urinary Bladder Neoplasms, Neoplasm Metastasis
RecruitingPhase 1
A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors
Metastatic Solid Tumor, Recurrent Solid Tumor
Not yet recruiting
Comparison of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy for 2-3 cm Renal Stones
Kidney Stones
RecruitingPhase 1/2
Dexamethasone for Ureteral STent Symptoms (DUSTS)
Ureteral Stent-Related Symptom
RecruitingObservational study
Comparison of Suction and Conventional Ureteral Access Sheaths in Kidney Stone Surgery
Kidney Calculi, Nephrolithiasis
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.
Mitchell Humphreys, MD principal investigator
Mayo Clinic
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uriprene® Degradable Temporary Ureteral Stent in people with Ureteral Diseases, run by Adva-Tec at 4 sites in United States.
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 5 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Cartledge, MS ((864) 506-0097, jcartledge@adva-tec.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Endpoint defined as the presence of the stent during the first 48 hours (time frame: 48 hours). The study lists 2 primary outcomes in all. 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 28 Oct 2026.