Degradable Ureteral Stent for Ureteral Disease

(URIPRENE Trial)

Recruiting at 4 trial locations

Overseen By Jennifer Cartledge, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Adva-Tec

Must not be taking: Blood thinners

Disqualifiers: Urinary tract infection, Urothelial cancer, Overactive bladder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 48 hours

87 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of ureteral stent, the Uriprene® Degradable Temporary Ureteral Stent, to determine its safety and effectiveness for individuals treated for kidney or ureteral stones with ureteroscopy. The stent temporarily supports the ureter (the tube connecting the kidney to the bladder) and then degrades naturally, potentially eliminating the need for a removal procedure. Individuals who have undergone successful ureteroscopy for kidney or ureteral stones and have no significant urinary tract issues may be suitable candidates for this trial. The primary goal is to evaluate the stent's performance and monitor any side effects. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could simplify post-procedure recovery for future patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude people who are currently taking blood thinners like warfarin. Anti-platelet agents are allowed.

What prior data suggests that the Uriprene® Degradable Temporary Ureteral Stent is safe for ureteral disease?

Research shows that the Uriprene® Degradable Temporary Ureteral Stent is designed to be safe for people. Studies have examined its effectiveness without requiring additional medical intervention, and the results are promising. The primary goal has been to ensure that the stent drains properly and degrades as expected over time.

Although specific side effects are not detailed, the trial remains in early stages, so safety is still being confirmed. Ongoing research into its safety and effectiveness demonstrates a commitment to ensuring it is well-tolerated. If the stent functions as intended, it could result in fewer complications compared to traditional stents.

Overall, the Uriprene® stent aims to provide a safe option for managing ureteral issues, and continued research will offer clearer insights into its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Uriprene® Degradable Temporary Ureteral Stent is unique because it dissolves naturally in the body, eliminating the need for a second procedure to remove it. Traditional ureteral stents often require an additional surgery for removal, which can be inconvenient and uncomfortable for patients. Researchers are excited about Uriprene® because its degradable nature reduces the risk of complications and improves patient comfort by avoiding the need for a follow-up procedure. This innovative approach to stenting could make recovery easier and more efficient for those dealing with ureteral or renal stone fragments.

What evidence suggests that the Uriprene® Degradable Temporary Ureteral Stent is effective for ureteral disease?

Research has shown that the Uriprene® Degradable Temporary Ureteral Stent, which participants in this trial will receive, effectively treats ureteral issues. In studies with animals, such as beagles, this stent successfully prevented kidney swelling due to urine buildup and swelling of the ureter. The stent allows urine to drain while gradually softening and breaking down over time, potentially reducing the need for removal procedures. Previous studies demonstrated that the stent is safe and effective for drainage. These findings suggest it could be a promising option for people being treated for ureteral stones. ^{2 6 7 8 9}

Who Is on the Research Team?

Mitchell Humphreys, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults aged 21-80 with unilateral ureteral or renal stones who've had a successful, uncomplicated ureteroscopy. They must be able to fit one of the specified stent sizes and not have urinary tract abnormalities, active infections, severe kidney dysfunction, or certain other medical conditions. Women must use reliable contraception.

Inclusion Criteria

I had a successful kidney stone removal surgery without complications.

You need to have a body size that can fit a specific length of ureteral stent as determined by the doctor.

I am between 21 and 80 years old.

Exclusion Criteria

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.

I have a serious illness and am expected to live less than a year.

Any condition, in the opinion of the investigator, that would deem a subject as ineligible for treatment with the Uriprene® Stent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Placement of the Uriprene® Degradable Temporary Ureteral Stent following uncomplicated ureteroscopy

48 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including stent degradation and adverse events

90 days

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Uriprene® Degradable Temporary Ureteral Stent

Trial Overview The Uriprene® Degradable Temporary Ureteral Stent's safety and performance are being tested in this non-randomized study across multiple centers. The stent is designed for patients following an uncomplicated procedure to remove kidney stones.

How Is the Trial Designed?

Group I: Placement of ureteral stent post ureteroscopy Experimental Treatment 1 Intervention

Subjects with unilateral ureteral or renal stone fragments who have undergone an uncomplicated ureteroscopy (UURS)

Uriprene® Degradable Temporary Ureteral Stent is already approved in United States, European Union for the following indications:

Approved in United States as Uriprene for:

• Temporary ureteral stenting following uncomplicated ureteroscopy

Approved in European Union as Uriprene for:

• Temporary ureteral stenting following uncomplicated ureteroscopy

Who Is Running the Clinical Trial?

Adva-Tec

Lead Sponsor

Trials

2

Recruited

100+

Northwest Clinical Research Group

Collaborator

Trials

1

Recruited

90+

Published Research Related to This Trial

In a study involving nine beagles, the use of a biodegradable ureteral stent effectively prevented hydronephrosis and hydroureter in injured ureters, while these complications occurred in all unstented ureters.

The biodegradable stent not only protected renal function but also improved kidney washout times, indicating its potential as a beneficial treatment for ureteral injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introduction to biodegradable polylactic acid ureteral stent application for treatment of ureteral war injury. Li, G., Wang, ZX., Fu, WJ., et al.[2019]

The novel biodegradable ureteral stents began degrading at 1 week and were completely degraded by 4 weeks, showing predictable degradation and good biocompatibility compared to standard biostable stents.

While both stents caused similar levels of hydronephrosis in the first 2 weeks, the biodegradable stents resulted in less hydronephrosis at 3 and 4 weeks, indicating their effectiveness in providing temporary renal drainage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Braided thin-walled biodegradable ureteral stent: preliminary evaluation in a canine model. Zhang, MQ., Zou, T., Huang, YC., et al.[2016]

In a study involving 30 healthy female pigs, a new hybrid metallic ureteral stent significantly reduced the formation of urothelial hyperplasia (21% vs 70%) compared to a standard stent, indicating improved safety and efficacy.

The hybrid stent also demonstrated lower rates of stent migration (6.6% vs 33.3%) and a higher success rate in maintaining ureteral patency after 6 months (86.6% vs 47%), suggesting it is a more effective option for treating ureteral strictures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation in an animal model of a hybrid covered metallic ureteral stent: a new design. Soria, F., Morcillo, E., Pamplona, M., et al.[2013]

The biodegradable antireflux ureteral stent (BDG-ARS) effectively prevented vesicoureteral reflux (VUR) in all tested ureters, indicating its potential for safer urinary tract interventions.

The BDG-ARS demonstrated a controlled and predictable degradation over 3 to 6 weeks without producing obstructive fragments, which may reduce complications associated with traditional ureteral stents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a New Design of Antireflux-biodegradable Ureteral Stent in Animal Model. Soria, F., Morcillo, E., Serrano, A., et al.[2018]

In a study involving 16 female Yorkshire pigs, 90% of the biodegradable Uriprene™ stents completely degraded within 4 weeks, demonstrating their effectiveness and safety as an alternative to traditional polymer stents.

The biodegradable stents provided equivalent drainage and significantly less hydronephrosis compared to biostable stents, indicating they may reduce complications associated with long-term stent use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo evaluation of the third generation biodegradable stent: a novel approach to avoiding the forgotten stent syndrome. Chew, BH., Paterson, RF., Clinkscales, KW., et al.[2013]

The biodegradable ureteral stent effectively prevented hydronephrosis and hydroureter in dogs with ureteral injuries, demonstrating its efficacy in treating such injuries.

Unlike the double-J stent, which showed signs of calcification over time, the biodegradable stent completely degraded within 120 days without any calcification, suggesting a safer profile for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of a biodegradable ureteral stent versus the traditional double-J stent for the treatment of ureteral injury: an experimental study. Fu, WJ., Wang, ZX., Li, G., et al.[2016]

The biodegradable ureteral stent, BraidStent-SF-MMC, effectively released mitomycin for the first 12 hours, demonstrating its potential for controlled drug delivery in treating upper urinary tract urothelial carcinoma in a study involving 14 female pigs.

While the stent showed a 67.5% success rate and no systemic toxic effects, complications included ureteral strictures and obstructive fragments, highlighting the need for further refinement in stent design to improve safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Animal model assessment of a new design for a coated mitomycin-eluting biodegradable ureteral stent for intracavitary instillation as an adjuvant therapy in upper urothelial carcinoma. Soria, F., Delacruz, JE., Aznar-Cervantes, SD., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02032316

NCT02032316 | Feasibility Study of the Uriprene Stent ... Primary Objective: To assess the safety and feasibility of the Uriprene® Stent by assessing the time to complete degradation or the passage of ...

2. uclahealth.org uclahealth.org/clinical-trials/safety-and-device-performance-uriprener-degradable-temporary

Safety and Device Performance of the Uriprene® ... A prospective, multi-center, non-randomized trial to demonstrate safety and device performance of the ADVA-Tec Uriprene® Degradable Temporary Ureteral Stent.

3. withpower.com withpower.com/trial/phase-ureteral-diseases-8-2021-2fd5b

Degradable Ureteral Stent for Ureteral Disease In a study involving nine beagles, the use of a biodegradable ureteral stent effectively prevented hydronephrosis and hydroureter in injured ureters, while ...

4. sbir.gov sbir.gov/awards/182945

Award | SBIR Uriprene is a composite tubular structure that provides drainage like other ureteral stents, but softens after implantation and ultimately degrades into ...

5. trial.medpath.com trial.medpath.com/clinical-trial/8d7011ba6cab226d/nct04565795-uriprene-clinical-study-safety-performance

Safety and Device Performance of the Uriprene® Degradable ... 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 ...

6. trial.medpath.com trial.medpath.com/clinical-trial/8d7011ba6cab226d/uriprene-clinical-study-safety-performance

Safety and Device Performance of the Uriprene® Degradable ... 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 ...

7. clinicaltrials.ucsd.edu clinicaltrials.ucsd.edu/trial/NCT04565795

Device Performance of the Uriprene® Degradable Temporary ... The study is intended to assess the safety and efficacy of the Uriprene® Stent by assessing adequate intervention-free drainage during use and ...

8. cms.gov cms.gov/httpswwwcmsgovmedicarecoverageideapproved-ide-studies/g200057-nct04565795

G200057-NCT04565795 Study Title. URIPRENE: Clinical Study to Evaluate the Safety and Device Performance of the ADVA-Tec Uriprene® Degradable Temporary Ureteral Stent Following ...

9. ufhealth.org ufhealth.org/clinical-trials/uriprene

URIPRENE 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 ...