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

Not Applicable

Not yet recruiting

• Conditions: Urinary Lithiasis

• Registration Number: NCT06719089
• Lead Sponsor: Hydrumedical

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.

Detailed Description

Multicentric, randomized, controlled clinical study comprising both phases of the pre-market device clinical development stage: pilot and pivotal. The first exploratory phase of the study (16 participants) will assess the safety of Hydrustent® for the first time in humans, while providing preliminary results on its efficacy. Following this, the second phase is confirmatory (118 participants), allowing the collection of the information necessary to evaluate the clinical performance and safety of Hydrustent®.

Study Timeline

• Study First Submitted: 2024-10-04
• Study First Submitted QC: 2024-12-02
• Study First Posted: 2024-12-05
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-16
• Study Start: 2025-02-01
• Primary Completion: 2026-10-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Primary safety endpoint assessed through adverse events and device deficiencies (Pilot and pivotal phases)	From surgery to the end of treatment at day 28	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.
Primary efficacy outcome assessed by the urine drainage after stent placement (Pivotal phase)	From surgery to day 1	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.

Secondary Outcome Measures

Name	Time	Method
Overall clinical success (efficacy) by evaluating the urine drainage after stent placement (Pilot phase)	From surgery to the end of treatment at day 28	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.
Overall clinical success by evaluating the urine drainage after stent placement (Pivotal phase)	From surgery to the end of treatment at day 28	Urine patency will be assessed using a composite endpoint based on the following criteria: 1. 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).; 2. CT scan to assess the adequate upper urinary tract urine drainage (defined as the absence of significative hydronephrosis); 3. Lack of surgical intervention in the stented ureter.
Overall safety assessed through adverse events and device deficiencies (Pilot and pivotal phases)	From surgery to the end of study at day 90	Evaluation of the number, severity, and intensity of AEs at least possibly related to the devices occurring and number, type and severity of DDs.
Assessment of the durability of the experimental device (Pilot and pivotal phases)	Day 1	Presence of an intact device with no radiographic evidence of breakage or dissolution assessed by radiological assessment
Technical success of the experimental device (Pilot and pivotal phases)	Day 28	Complete degradation of the investigational stent as measured by radiological assessment (CT scan).
Devices tolerability through the assessment of urinary symptoms (Pilot and pivotal phases)	Screening phase, during the treatment phase and up to the end of the study at day 90	Assessment of urinary symptoms via the International Prostate Symptom Score (IPSS) for male participants.; The questionnaire consists of two sections: fhe first section includes a 7-item tool, with each item scored from 0 to 5, generating a total score ranging from 0 to 35 points. The second section assesses quality of life, with scores ranging from 0 to 6. Lower scores indicate fewer urinary symptoms and better quality of life related to urinary symptoms.

Trial Locations

Locations (2)

Unidade Local de Unidade Local de Saúde do Alto Ave (ULSAAVE), E.P.E; 🇵🇹 Guimarães, Braga, Portugal

Unidade Local de Saúde da Região de Aveiro (ULSRA), E.P.E.; 🇵🇹 Aveiro, Portugal