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

NCT06719089 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2026-04-29

No results posted yet for this study

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

Interventions

DEVICE

PolyUrethane Double Loop Ureteral Stent

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

DEVICE

Biodegradable double loop ureteral stent

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.

Sponsors & Collaborators

  • Blueclinical, Ltd.

    collaborator OTHER

  • Clinical Academic Center (2CA-Braga)

    collaborator OTHER

  • Hydrumedical

    lead INDUSTRY

Principal Investigators

  • Coordinating Investigator · Paulo Mota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-09
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06719089 on ClinicalTrials.gov