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Tests treatment safety and results for Urinary Lithiasis
Official title Evaluation of the Safety and Performance of the Hydrustent® Biodegradable Hydrogel Ureteral Stent
ClinicalTrials.gov ID: NCT06719089
What this study is testing
- What it's testing
- 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?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Pilot phase: Inclusion:
- people with the ability to understand the requirements of the study, who have provided written ICF before any assessment is performed, and are...
- Adult patients, males or females, aged between 18 and 70 years old;
- people with ureteral and/or renal stones who have undergone a successful, uncomplicated, unilateral URS and RIRS, with clinical indication to place a...
- people 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;
See the full eligibility criteria
Who can join
- Pilot phase: Inclusion:
- people 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;
- people 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;
- people 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...
- 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:
- people with urinary anatomic malformations or previous relevant surgical modifications.
- people with known/suspicion of urothelial or renal tumour;
- people with known/suspicion of extrinsic compression of the ureter and/or stricture;
- people with known/suspicion of ureteral perforation and/or fistula;
- people under active treatment for bladder outlet obstruction (e.g., benign prostatic obstruction), neurogenic bladder, overactive bladder, and/or urge urinary incontinence;
- people with a solitary kidney;
- people with calculated GFR below 60 mL/min/1.73m2;
- people with known renal insufficiency or chronic impairment;
- people with post-operative suspicion/known incomplete stone fragmentation with the presence of relevant residual urinary lithiasis, requiring an additional procedure;
- people with active history of bleeding diathesis or currently taking anticoagulants (except antiplatelet agents);
- people with pre-operative evidence of staghorn calculi;
- people with suspicious/diagnosed UTI at the time of US placement, or pre-operative positive urine culture or active UTI taking antibiotic medication;
- people with contrast allergy; Pregnant, lactating, or women of childbearing potential who do not employ a highly effective contraceptive method as judged by the medical investigator, and/or who are not willing to use a...
- Subject with a known severe psychiatric disorder, substance abuse, or other reason for being unable to follow study FU instructions or unable to reliably complete patient questionnaires;
- people with signs of local or systemic acute/active or chronic infections;
- people with sensibility or known hypersensitivity to the implantable materials;
- people with ureteral blockage or stricture;
- people with failed guidewire placement or failed ureteroscopy access;
- people with suspect ureteral avulsion;
- people with untreated infected urinary obstruction of the kidneys (pyonephrosis);
- people with vascular abnormalities of the renal pelvis outlet;
- people with unexplained haematuria;
- people with significant urethral obstruction;
- people with concomitant or untreated bladder lithiasis;
- Any other condition that would deem a subject ineligible for treatment with the investigational device in the opinion of the medical investigator;
- Subject is known to be currently enrolled in another investigational study. Pivotal phase: Inclusion:
- people with the ability to understand the requirements of the study, who have provided written or oral informed consent form before any assessment is performed, and are willing to undergo all FU assessments according to...
- Adult patients, males or females, aged \> 18 years old;
- people with ureteral and/or renal stones who have undergone a successful, unilateral ureteroscopy and retrograde intra-renal surgery, with clinical indication to place a post-operative US, as judged by the medical...
- people 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...
- 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:
- Urinary anatomic malformations or previous relevant surgical modifications;
- people with known/suspicion of urothelial or renal tumour;
- people with known/suspicion of extrinsic compression of the ureter and/or stricture;
- people with known/suspicion of ureteral perforation and/or fistula;
- people under active treatment for bladder outlet obstruction (e.g., benign prostatic obstruction), neurogenic bladder, overactive bladder, and/or urge urinary incontinence;
- people with a solitary kidney;
- people with calculated Glomerular Filtration Rate below 60 mL/min/1.73m2;
- people with post-operative suspicion/known incomplete stone fragmentation with the presence of relevant residual urinary lithiasis, requiring an additional procedure;
- people with active history of bleeding diathesis or currently taking anticoagulants (except antiplatelet agents);
- people with pre-operative evidence of staghorn calculi;
- people with suspicious/diagnosed urinary tract infection at the time of ureteral stent insertion, or pre-operative positive urine culture or active urinary tract infection taking antibiotic medication;
- people with contrast allergy;
- Pregnant, lactating, or women of childbearing potential who do not employ a highly effective contraceptive method and/or who are not willing to use a highly effective contraception for the duration of study...
- Subject with a known severe psychiatric disorder, substance abuse, or other reason for being unable to follow study FU instructions or unable to reliably complete patient questionnaires;
- people with signs of local or systemic acute/active or chronic infections;
- people with sensibility or known hypersensitivity to the implantable materials;
- people with ureteral blockage or stricture;
- people with failed guidewire placement or failed ureteroscopy access;
- people with suspect ureteral avulsion;
- people with untreated infected urinary obstruction of the kidneys (pyonephrosis);
- people with vascular abnormalities of the renal pelvis outlet;
- people with unexplained haematuria;
- people with significant urethral obstruction;
- people with concomitant or untreated bladder lithiasis;
- Any other condition that would deem a subject ineligible for treatment with the investigational device in the opinion of the medical investigator;
- Subject is known to be currently enrolled in another investigational study.
The study team makes the final eligibility decision.
Where it's taking place
- Aveiro, Aveiro District, Portugal
- Guimarães, Braga District, Portugal
- Lisbon, Portugal
- Viana do Castelo, Portugal
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aveiro, Aveiro District, Portugal; Guimarães, Braga District, Portugal; Lisbon, Portugal; Viana do Castelo, Portugal. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.