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

NCT06719089 | Recruiting DMC

• 1 other identifier: Hydrustent
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Urinary Lithiasis

Keywords

Biodegradable ureteral stent; kidney stones; Hydrustent; Hydrumedical

Outcome Measures

Primary Outcomes (2)

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

  Evaluation of the number, severity, and intensity of AEs and DDs at least possibly related to either the investigational device or the comparator device that occurred within 28±1 days of stent placement.

  From surgery to the end of treatment at day 28

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

  Urine patency will be assessed using a composite endpoint based on the following criteria: 1. Diuresis (range within 0.5 to 1.5 mL/kg/h). 2. Creatinine levels in blood tests (range within 0.7 to 1.2 mg/dL for men and 0.5 to 1.0 mg/dL for women). 3. CT scan to assess the adequate upper urinary tract urine drainage (defined as the absence of significative hydronephrosis) 4. Lack of surgical intervention in the stented ureter.

  From surgery to day 1

Secondary Outcomes (10)

• Overall clinical success (efficacy) by evaluating the urine drainage after stent placement (Pilot phase)

  From surgery to the end of treatment at day 28

• Overall clinical success by evaluating the urine drainage after stent placement (Pivotal phase)

  From surgery to the end of treatment at day 28

• Overall safety assessed through adverse events and device deficiencies (Pilot and pivotal phases)

  From surgery to the end of study at day 90

• Assessment of the durability of the experimental device (Pilot and pivotal phases)

  Day 1

• Technical success of the experimental device (Pilot and pivotal phases)

  Day 28

Study Arms (2)

Rocamed RocaJJ Soft

ACTIVE COMPARATOR

Device: PolyUrethane Double Loop Ureteral Stent

Hydrustent®

EXPERIMENTAL

Device: Biodegradable double loop ureteral stent

Interventions

Biodegradable double loop ureteral stent DEVICE

This ureteral stent is based on natural polymers and degrades inside the human body without causing obstruction, avoiding the need of a second surgery for stent removal and minimizing complications related to encrustation and bacterial infections.

Hydrustent®

PolyUrethane Double Loop Ureteral Stent DEVICE

This ureteral stent is a double J made of 100% polyurethan, heat-sensitive and radiopaque for excellent patient tolerance and high incrustation resistance.

Rocamed RocaJJ Soft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hydrumedical: lead
• Blueclinical, Ltd.: collaborator
• Clinical Academic Center (2CA-Braga): collaborator

Study Sites (4)

Unidade Local de Saúde da Região de Aveiro (ULSRA), E.P.E.

Aveiro, Aveiro District, 3814-501, Portugal

RECRUITING

Unidade Local de Unidade Local de Saúde do Alto Ave (ULSAAVE), E.P.E

Guimarães, Braga District, 4835-044, Portugal

RECRUITING

Hospital CUF Tejo

Lisbon, 1350-352, Portugal

NOT YET RECRUITING

Unidade Local de Saúde do Alto Minho (ULSAM)

Viana do Castelo, 4904-858, Portugal

NOT YET RECRUITING

MeSH Terms

Conditions

Urolithiasis; Kidney Calculi

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nephrolithiasis; Kidney Diseases; Urinary Calculi; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Coordinating Investigator

  Paulo Mota

  STUDY CHAIR

Central Study Contacts

Ferreira (Sponsor)

CONTACT

+351 253 573 460; clinicalstudies@hydrumedical.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Investigators that will place the stent will not be the same that will perform the follow-up visits.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: December 5, 2024
• Study Start: September 9, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PT (4)