Urinary LithiasisHydrustentNCT06719089
Evaluation of the Safety and Performance of the Hydrustent® Biodegradable Hydrogel Ureteral Stent
A study testing Biodegradable double loop ureteral stent and PolyUrethane Double Loop Ureteral Stent in people with Urinary Lithiasis, run by Hydrumedical at 4 sites in Portugal.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Lithiasis
- What is being tested?
- Biodegradable double loop ureteral stent and PolyUrethane Double Loop Ureteral Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 4 sitesPortugal
- Study dates
- 9 Sep 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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;
Show all 53Show fewer
- 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:
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal4 sites, 4 recruiting
- Recruiting
Unidade Local de Saúde da Região de Aveiro (ULSRA), E.P.E.
Aveiro, Aveiro District, 3814-501
Study Coordination Team
Agostinho Cordeiro
- Recruiting
Unidade Local de Unidade Local de Saúde do Alto Ave (ULSAAVE), E.P.E
Guimarães, Braga District, 4835-044
Study Coordination Team
Viviana Azevedo
- Not yet recruiting
Hospital CUF Tejo
Lisbon, 1350-352
Study Coordination Team
Paulo Dinis
- Not yet recruiting
Unidade Local de Saúde do Alto Minho (ULSAM)
Viana do Castelo, 4904-858
Study Coordination Team
Hugo Coelho
About this study
Official title: Evaluation of the Safety and Performance of the Hydrustent® Biodegradable Hydrogel Ureteral Stent in Patients With Nephrolithiasis: A Multicentric, Randomized, Controlled Study
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:
Read more
- 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.
Read the 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®.
- Conditions
- Urinary Lithiasis
- Being tested
- Biodegradable double loop ureteral stent, PolyUrethane Double Loop Ureteral Stent
- Keywords
- Biodegradable ureteral stent, kidney stones, Hydrustent, Hydrumedical
- Medical subject headings
- Urolithiasis, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biodegradable double loop ureteral stentDevice
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.
PolyUrethane Double Loop Ureteral StentDevice
This ureteral stent is a double J made of 100% polyurethan, heat-sensitive and radiopaque for excellent patient tolerance and high incrustation resistance.
| Study group | Role | What they receive |
|---|---|---|
| Rocamed RocaJJ Soft | Active comparator | Not described Receives: Device: PolyUrethane Double Loop Ureteral Stent |
| Hydrustent® | Experimental | Not described Receives: Device: Biodegradable double loop ureteral stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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:
- Diuresis (range within 0.5 to 1.5 mL/kg/h).
- 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).
- CT scan to assess the adequate upper urinary tract urine drainage (defined as the absence of significative hydronephrosis)
- Lack of surgical intervention in the stented ureter.
Measured: From surgery to day 1
Secondary outcomes (10)
Overall clinical success (efficacy) by evaluating the urine drainage after stent placement (Pilot phase)
Urine patency will be assessed using a composite endpoint based on the following criteria:
- Diuresis (range within 0.5 to 1.5 mL/kg/h).
- 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).
- CT scan to assess the adequate upper urinary tract urine drainage (defined as the absence of significative hydronephrosis)
- Lack of surgical intervention in the stented ureter.
Measured: From surgery to the end of treatment at day 28
Overall clinical success by evaluating the urine drainage after stent placement (Pivotal phase)
Urine patency will be assessed using a composite endpoint based on the following criteria:
- 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).
- CT scan to assess the adequate upper urinary tract urine drainage (defined as the absence of significative hydronephrosis)
- Lack of surgical intervention in the stented ureter.
Measured: From surgery to the end of treatment at day 28
Overall safety assessed through adverse events and device deficiencies (Pilot and pivotal phases)
Evaluation of the number, severity, and intensity of AEs at least possibly related to the devices occurring and number, type and severity of DDs.
Measured: From surgery to the end of study at day 90
Assessment of the durability of the experimental device (Pilot and pivotal phases)
Presence of an intact device with no radiographic evidence of breakage or dissolution assessed by radiological assessment
Measured: Day 1
Technical success of the experimental device (Pilot and pivotal phases)
Complete degradation of the investigational stent as measured by radiological assessment (CT scan).
Measured: Day 28
Devices tolerability through the assessment of urinary symptoms (Pilot and pivotal phases)
Assessment of urinary symptoms via the Ureteral Stent Symptom Questionnaire (USSQ).
The total score of the questionnaire is the sum of all items across the following symptom sections: urinary symptoms, pain, sexual issues, general health, and work performance. A higher total score reflects a greater burden of symptoms and worse quality of life.
Measured: Screening phase, during the treatment phase and up to the end of the study at day 90
Devices tolerability through the assessment of urinary symptoms (Pilot and pivotal phases)
Assessment of urinary symptoms via the Visual Analog Scale (VAS). Study participants mark their symptom intensity on a continuous line 10 centimetres long, the extremes of which indicate "no pain" and "maximum pain". A higher score indicates greater pain intensity.
Measured: Screening phase, during the treatment phase and up to the end of the study at day 90
Devices tolerability through the assessment of urinary symptoms (Pilot and pivotal phases)
Assessment of urinary symptoms via the need of pain medication. If intervention for pain management is required, it suggests that the urinary symptoms are more severe.
Measured: During the treatment phase and up to the end of the study at day 90
Devices tolerability through the assessment of urinary symptoms (Pilot and pivotal phases)
Assessment of urinary symptoms via the International Index of Erectile Function (IIEF-5) for male participants.
The 5-item tool, with each item scored from 1 to 5, generates a total score ranging from 5 to 25 points. Lower scores indicate poorer sexual functioning, while higher scores reflect better erectile functioning.
Measured: Screening phase, during the treatment phase and up to the end of the study at day 90
Devices tolerability through the assessment of urinary symptoms (Pilot and pivotal phases)
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.
Measured: Screening phase, during the treatment phase and up to the end of the study at day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start9 Sep 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary LithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hydrumedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Blueclinical, Ltd., Clinical Academic Center (2CA-Braga)
- Responsible party
- Sponsor
- Investigators
- Coordinating Investigator, Study chair, Paulo Mota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719089
- Sponsor's protocol ID
- Hydrustent
- Acronym
- Hydrustent
- Status last verified
- Apr 2026
- First submitted
- 4 Oct 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Performance of the Hydrustent® Biodegradable Hydrogel Ureteral Stent in Patients With Nephrolithiasis: A Multicentric, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT06719089
- Acronym / sponsor ID
- Hydrustent / Hydrustent
- Conditions
- Urinary Lithiasis
- Keywords
- Biodegradable ureteral stent, kidney stones, Hydrustent, Hydrumedical
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- HydrumedicalIndustry (pharma, biotech, devices)
- Collaborators
- Blueclinical, Ltd., Clinical Academic Center (2CA-Braga)
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rocamed RocaJJ Soft | Active comparator | Device: PolyUrethane Double Loop Ureteral Stent |
| Hydrustent® | Experimental | Device: Biodegradable double loop ureteral stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (53 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biodegradable double loop ureteral stentThis 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. | Device | Hydrustent® |
| PolyUrethane Double Loop Ureteral StentThis ureteral stent is a double J made of 100% polyurethan, heat-sensitive and radiopaque for excellent patient tolerance and high incrustation resistance. | Device | Rocamed RocaJJ Soft |
Primary outcome
Primary safety endpoint assessed through adverse events and device deficiencies (Pilot and pivotal phases)
Time frame: 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)
Time frame: 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.
10 secondary outcomes
Overall clinical success (efficacy) by evaluating the urine drainage after stent placement (Pilot phase)
Time frame: From surgery to the end of treatment at day 28
Overall clinical success by evaluating the urine drainage after stent placement (Pivotal phase)
Time frame: From surgery to the end of treatment at day 28
Overall safety assessed through adverse events and device deficiencies (Pilot and pivotal phases)
Time frame: From surgery to the end of study at day 90
Assessment of the durability of the experimental device (Pilot and pivotal phases)
Time frame: Day 1
Technical success of the experimental device (Pilot and pivotal phases)
Time frame: Day 28
Devices tolerability through the assessment of urinary symptoms (Pilot and pivotal phases)
Time frame: Screening phase, during the treatment phase and up to the end of the study at day 90
Devices tolerability through the assessment of urinary symptoms (Pilot and pivotal phases)
Time frame: Screening phase, during the treatment phase and up to the end of the study at day 90
Devices tolerability through the assessment of urinary symptoms (Pilot and pivotal phases)
Time frame: During the treatment phase and up to the end of the study at day 90
Devices tolerability through the assessment of urinary symptoms (Pilot and pivotal phases)
Time frame: Screening phase, during the treatment phase and up to the end of the study at day 90
Devices tolerability through the assessment of urinary symptoms (Pilot and pivotal phases)
Time frame: Screening phase, during the treatment phase and up to the end of the study at day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Coordinating Investigator study chair
Paulo Mota
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biodegradable double loop ureteral stent and PolyUrethane Double Loop Ureteral Stent in people with Urinary Lithiasis, run by Hydrumedical at 4 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 53 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ferreira (Sponsor) (+351 253 573 460, clinicalstudies@hydrumedical.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary safety endpoint assessed through adverse events and device deficiencies (Pilot and pivotal phases) (time frame: From surgery to the end of treatment at day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.