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

Launched by HYDRUMEDICAL · Dec 2, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the Hydrustent® device, which is a biodegradable ureteral stent used to help maintain urinary flow after surgery for kidney stones. The study aims to find out if the Hydrustent® is safe and effective in keeping the ureter open, which is the tube that carries urine from the kidney to the bladder. Researchers will compare the Hydrustent® to a standard stent to see if it works just as well or better. They will also look at how long the stent lasts, whether it reduces urinary symptoms, and if it can eliminate the need for another surgery to remove it.

To participate in this study, individuals must be adults aged 18 to 70 who have had surgery to remove kidney stones and need a stent placed afterward. Participants will be monitored for three months, which includes follow-up visits, questionnaires, and some tests to check their recovery. It’s important to note that there are specific criteria that might exclude someone from participating, like having certain urinary conditions or infections. Overall, this trial is designed to gather important information about a new device that could improve post-surgery care for patients dealing with kidney stones.

Gender

ALL

Eligibility criteria

• 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), neurogenic bladder, overactive bladder, and/or urge urinary incontinence;
• • Subjects with a solitary kidney;
• • Subjects with calculated GFR below 60 mL/min/1.73m2;
• • Subjects with known renal insufficiency or chronic impairment;
• • Subjects with post-operative suspicion/known incomplete stone fragmentation with the presence of relevant residual urinary lithiasis, requiring an additional procedure;
• • Subjects with active history of bleeding diathesis or currently taking anticoagulants (except antiplatelet agents);
• • Subjects with pre-operative evidence of staghorn calculi;
• • Subjects with suspicious/diagnosed UTI at the time of US placement, or pre-operative positive urine culture or active UTI taking antibiotic medication;
• • Subjects 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 highly effective contraception for the duration of study participation;
• • 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;
• • Subjects with signs of local or systemic acute/active or chronic infections;
• • Subjects with sensibility or known hypersensitivity to the implantable materials;
• • Subjects with ureteral blockage or stricture;
• • Subjects with failed guidewire placement or failed ureteroscopy access;
• • Subjects with suspect ureteral avulsion;
• • Subjects with untreated infected urinary obstruction of the kidneys (pyonephrosis);
• • Subjects with vascular abnormalities of the renal pelvis outlet;
• • Subjects with unexplained haematuria;
• • Subjects with significant urethral obstruction;
• • Subjects 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:
• • Subjects 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 the specified schedule;
• • Adult patients, males or females, aged \> 18 years old;
• • Subjects 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 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:
• • 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), neurogenic bladder, overactive bladder, and/or urge urinary incontinence;
• • Subjects with a solitary kidney;
• • Subjects with calculated Glomerular Filtration Rate below 60 mL/min/1.73m2;
• • Subjects with post-operative suspicion/known incomplete stone fragmentation with the presence of relevant residual urinary lithiasis, requiring an additional procedure;
• • Subjects with active history of bleeding diathesis or currently taking anticoagulants (except antiplatelet agents);
• • Subjects with pre-operative evidence of staghorn calculi;
• • Subjects 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;
• • Subjects 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 participation;
• • 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;
• • Subjects with signs of local or systemic acute/active or chronic infections;
• • Subjects with sensibility or known hypersensitivity to the implantable materials;
• • Subjects with ureteral blockage or stricture;
• • Subjects with failed guidewire placement or failed ureteroscopy access;
• • Subjects with suspect ureteral avulsion;
• • Subjects with untreated infected urinary obstruction of the kidneys (pyonephrosis);
• • Subjects with vascular abnormalities of the renal pelvis outlet;
• • Subjects with unexplained haematuria;
• • Subjects with significant urethral obstruction;
• • Subjects 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.