RecruitingNot Applicable

Evaluation of the Safety and Performance of the Hydrustent® Biodegradable Hydrogel Ureteral Stent

Portugal134 participantsStarted 2025-09-09

Plain-language summary

The goal of this clinical investigation is to evaluate whether the Hydrustent® medical device is safe and if maintain the urinary flow inside the ureter in adults. The main questions it aim to answer are: * Does Hydrustent® maintain urinary patency post-surgery in adults? * What medical issues do participants experience while using Hydrustent®? Researchers will compare the Hydrustent® medical device to a comparator (a standard medical device used in clinical practice) to determine whether Hydrustent® is at least non-inferior in terms of safety and efficacy. Other questions that the study will answer are: * Does Hydrustent® exhibit a durability of at least 24 hours? * Does Hydrustent® prevents the need of the surgical procedure to remove the ureteral stent? * Does Hydrustent® reduce urinary symptoms associated with a ureteral stent? Participants will: * Have either the Hydrustent® or a comparator device inserted following the removal of ureteral or renal stones via endourological techniques. * Be monitored for 3 months post-surgery through regular follow-up visits. * Complete questionnaires and undergo imaging exams, as well as blood and urine analyses to assess recovery.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Pilot phase: Inclusion: * Subjects with the ability to understand the requirements of the study, who have provided written ICF before any assessment is performed, and are willing to undergo all FU assessments according to the specified schedule; * Adult patients, males or females, aged between 18 and 70 years old; * Subjects with ureteral and/or renal stones who have undergone a successful, uncomplicated, unilateral URS and RIRS, with clinical indication to place a post-operative US, as judged by the medical investigator; * Subjects with a height and body sizeable to accommodate a 22, 24, 26, 27 and 28 cm long US and diameter of 7 Fr, as judged by the medical investigator; * Female participants of childbearing potential and male participants whose partner is of childbearing potential must be willing to ensure that they or their partner use protocol's recommended effective contraception methods during all the trial duration; * Male participants must agree to refrain from donation of semen from the start of the study treatment up to the end of the study. Exclusion: * Subjects with urinary anatomic malformations or previous relevant surgical modifications. * Subjects with known/suspicion of urothelial or renal tumour; * Subjects with known/suspicion of extrinsic compression of the ureter and/or stricture; * Subjects with known/suspicion of ureteral perforation and/or fistula; * Subjects under active treatment for bladder outlet obstruction (e.g., benign prostatic obstruction…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Primary safety endpoint assessed through adverse events and device deficiencies (Pilot and pivotal phases)

Timeframe: From surgery to the end of treatment at day 28

Primary efficacy outcome assessed by the urine drainage after stent placement (Pivotal phase)

Timeframe: From surgery to day 1

Trial details

NCT IDNCT06719089

SponsorHydrumedical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Ferreira (Sponsor)

+351 253 573 460 clinicalstudies@hydrumedical.pt

View on ClinicalTrials.gov More Urinary Lithiasis trials