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Dissolving stent could spare kidney stone patients a second procedure

NCT ID NCT04565795

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study is testing a new type of ureteral stent that is designed to slowly dissolve and pass out of the body on its own after being placed during kidney stone surgery. The goal is to see if it safely drains urine and breaks down within 90 days, so patients don't need a second procedure to remove it. About 87 adults who had a straightforward stone removal will be followed for three months to check for complications and how well the stent works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Uriprene® Degradable Temporary Ureteral Stent
What this could lead to
If it works, this could offer a safer, more convenient option for patients needing a temporary stent after kidney stone surgery, eliminating the need for a second procedure to remove it.
What could go wrong
This is an early-stage, non-randomized trial with only 87 participants, so results may not apply to everyone. The stent might not degrade as expected or could cause side effects like pain or infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 87 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2022

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subjects who are \>21, \<80 years of age; inclusive of males and females. 2. Subjects with unilateral ureteral or renal stones who have undergone a successful, uncomplicated ureteroscopy (UURS). 3. 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. 4. 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. 5. 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. Exclusion Criteria: 1. Subjects with a history of an anatomical abnormality of the urinary tract. 2. Presence of ureteral fistula. 3. Presence of urothelial cancer, ureteral tumor, or renal tumor. 4. Presence of extrinsic compression of the ureter. 5. Presence of ureteral blockage or stricture. 6. Bladder outlet obstruction or neurogenic bladder. 7. Subjects with known/diagnosed overactive bladder (OAB). 8. Subjects with known/diagnosed urge urinary incontinence (UUI). 9. Subjects with a known, active upper or lower urinary tract infection at the time of stent insertion. 10. Subjects with creatinine level of ˃2.5 mg/dl. 11. 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. 12. Impacted ureteral stones still in place and/or incomplete stone fragmentation. 13. Ureteral perforation. 14. Staghorn calculi. 15. Subjects with a solitary kidney. 16. History of bleeding diathesis or currently taking blood thinners such as warfarin (anti- platelet agents are allowed). 17. Contrast allergy that cannot be adequately pre-treated. 18. 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. 19. Any condition, in the opinion of the investigator, that would deem a subject as ineligible for treatment with the Uriprene® Stent. 20. Subject has a known significant concomitant illness with a life expectancy of \<1 year. 21. Subject is known to be currently enrolled in another investigational trial.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mayo Clinic Arizona

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • The Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • University of California Los Angeles

    RECRUITING

    Los Angeles, California, 90404, United States

  • University of Florida

    RECRUITING

    Gainesville, Florida, 32610, United States

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