Actively Recruiting
Evaluation of the Safety and Performance of the Hydrustent® Biodegradable Hydrogel Ureteral Stent
Led by Hydrumedical · Updated on 2026-04-29
134
Participants Needed
4
Research Sites
68 weeks
Total Duration
On this page
Sponsors
H
Hydrumedical
Lead Sponsor
B
Blueclinical, Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of the Safety and Performance of the Hydrustent® Biodegradable Hydrogel Ureteral Stent
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged between 18 and 70 years (pilot phase) or older than 18 years (pivotal phase)
- Able to understand study requirements and provide written or oral informed consent
- Have ureteral and/or renal stones and have undergone successful, uncomplicated unilateral ureteroscopy and/or retrograde intra-renal surgery
- Have body size suitable for a 22 to 28 cm long, 7 Fr diameter ureteral stent
- Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception during the study
- Male participants must agree to refrain from semen donation during the study
You will not qualify if you...
- Urinary tract anatomical malformations or prior significant urinary surgery
- Known or suspected urothelial or renal tumors
- Known or suspected extrinsic ureteral compression or strictures
- Known or suspected ureteral perforation or fistula
- Active treatment for bladder outlet obstruction, neurogenic bladder, overactive bladder, or urge urinary incontinence
- Solitary kidney
- Glomerular filtration rate below 60 mL/min/1.73m2
- Known renal insufficiency or chronic impairment
- Incomplete stone fragmentation requiring additional procedure
- Active bleeding disorders or current anticoagulant use (except antiplatelet agents)
- Pre-operative evidence of staghorn calculi
- Active or suspected urinary tract infection or positive urine culture at time of stent placement
- Allergy to contrast agents
- Pregnant, lactating, or women of childbearing potential not using highly effective contraception
- Severe psychiatric disorders, substance abuse, or inability to comply with study procedures
- Signs of acute or chronic infections
- Sensitivity or allergy to implant materials
- Ureteral blockage or strictures
- Failed guidewire placement or ureteroscopy access
- Suspected ureteral avulsion
- Untreated infected urinary obstruction (pyonephrosis)
- Vascular abnormalities of renal pelvis outlet
- Unexplained blood in urine
- Significant urethral obstruction
- Untreated bladder stones
- Participation in another investigational study
- Any other condition making the participant ineligible according to the investigator
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Unidade Local de Saúde da Região de Aveiro (ULSRA), E.P.E.
Aveiro, Aveiro District, Portugal, 3814-501
Actively Recruiting
2
Unidade Local de Unidade Local de Saúde do Alto Ave (ULSAAVE), E.P.E
Guimarães, Braga District, Portugal, 4835-044
Actively Recruiting
3
Hospital CUF Tejo
Lisbon, Portugal, 1350-352
Not Yet Recruiting
4
Unidade Local de Saúde do Alto Minho (ULSAM)
Viana do Castelo, Portugal, 4904-858
Not Yet Recruiting
Research Team
F
Ferreira (Sponsor)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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