Kidney StonesDISON INCT07712861
DISON I - Directly Integrated Suction and Optics System for the Treatment of Nephrolithiasis
A study testing RIRS with Investigational Device in people with Kidney Stones and Urolithiasis, run by Ventaris Surgical Incorporated at 5 sites in 5 countries.
Trial summary
A single-arm, multicenter, international, prospective interventional study designed to evaluate the safety and performance of an investigational device during retrograde intrarenal surgery for the treatment of renal calculi. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Kidney Stones, Urolithiasis, Nephrolithiasis
- What is being tested?
- RIRS with Investigational Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Oct 2026to Aug 2028
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of calyceal and/or renal pelvis calculi
- Age from 18 through 85 years
- Maximum stone diameter between 0.5cm - 2.0cm as assessed by Non-Contrast CT scan (≤ 2 mm slice thickness) within 90 days prior to treatment
- Willing and able to comply with all study requirements
- Signs study-specific informed consent form
Who cannot join
- Diagnosis of calculus of the ureter
- BMI ≥ 42
- Significant renal impairment: stage 3a CKD or higher (eGFR <59mL/min)
- Active infection, including urinary tract infection
- Urological anatomic/congenital abnormalities
- Previous history of struvite stone in the same renal unit
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- Taking anticoagulants that cannot be stopped before and after procedure or known coagulopathy or platelet disorder (except aspirin below 100mg/d)
- History of gross hematuria
- Solitary functioning kidney
- Known allergy to device materials
- Any severe illness that would prevent complete study participation or confound study results
- Serious concurrent medical conditions such as heart disease (e.g., myocardial infarction within 30 days, congestive heart failure - NYHA Class IV), pulmonary disease or uncontrolled diabetes.
- History of open-heart surgery, or cardiac arrest < 180 days prior to the date of informed consent
- ASA III or higher
- Taking systemic immune suppressants
- Dementia or psychiatric condition that prevents the participant from completing required follow up
- Contraindication to both general and spinal anesthesia
- Participating in another investigational study that could affect responses to the study device
- Unwilling to accept a transfusion should one be required
- Pregnant or considering getting pregnant within the next 3 months
- Undergoing bilateral ureteroscopy
Trial locations and contacts
5 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 5 countries
Argentina1 site
Hospital Alemán
Buenos Aires
Head of Clinical Investigations, (011) 4827 7000 ext. 2286/ 7039, pperez@hospitalaleman.com
Canada1 site
Centre hospitalier de l'Universite de Montreal (CHUM)
Montreal
Research Coordinator, 514-890-8000 ext. 22931, abbas.guennoun.chum@ssss.gouv.qc.ca
Hong Kong1 site
The Chinese University of Hong Kong
Hong Kong
Research Coordinator, 3505 2211, francolai@surgery.cuhk.edu.hk
India1 site
Muljibhai Patel Urological Hospital
Nadiād
Research Coordinator, 912682520328, monil.parmar@mpuh.in
New Zealand1 site
Tauranga Urology Research Limited
Tauranga
Research Coordinator, (07) 579 0466, marg@urobop.co.nz
About this study
Official title: DISON I - Directly Integrated Suction and Optics System for the Treatment of Nephrolithiasis- A Multicenter Prospective Pilot Study
A single-arm, multicenter, international, prospective interventional study designed to evaluate the safety and performance of an investigational device during retrograde intrarenal surgery for the treatment of renal calculi.
- Conditions
- Kidney Stones, Urolithiasis, Nephrolithiasis
- Being tested
- RIRS with Investigational Device
- Keywords
- kidney stones, medical device, Urological procedure
- Medical subject headings
- Kidney Calculi, Urolithiasis, Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIRS with Investigational DeviceDevice
Investigational endourological device used during retrograde intrarenal surgery.
| Study group | Role | What they receive |
|---|---|---|
| Investigational endourological device used during retrograde intrarenal surgery. | Experimental | Not described Receives: Device: RIRS with Investigational Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure success
Successful completion of the planned procedure without device-related technical complications.
Measured: Intraoperative
Serious Adverse Device Effects (SADEs)
Serious adverse device effects related to the investigational device.
Measured: 30 days post-procedure
Stone-Free Status
Absence of residual stone fragments on CT imaging
Measured: 30 days post-procedure
Secondary outcomes (7)
Stone-Free Categories
Stone-free status according to predefined categories.
Measured: 30 days post-procedure
Intrarenal pressure assessment
Intrarenal pressure measured during the procedure.
Measured: Intraoperative
Procedure duration
Duration of the surgical procedure.
Measured: Intraoperative
Stone clearance
Amount of stone material removed during the procedure.
Measured: Intraoperative
Residual stone burden
Residual stone burden assessed by imaging.
Measured: 30 days post-procedure
Device- or procedure-related adverse event
Device- or procedure-related adverse event.
Measured: From procedure to 12 months post-procedure
Stone-related healthcare utilization
Healthcare utilization related to recurrent stone symptoms in the treated kidney.
Measured: From procedure to 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study startOct 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StonesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ventaris Surgical Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07712861
- Sponsor's protocol ID
- VS-0001
- Acronym
- DISON I
- Status last verified
- Jul 2026
- First submitted
- 11 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD will not be shared because this is an early feasibility study involving a small cohort of participants. The data set is limited and may contain information that could risk re-identification. Summary results and aggregate findings will be published following study completion.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DISON I - Directly Integrated Suction and Optics System for the Treatment of Nephrolithiasis- A Multicenter Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT07712861
- Acronym / sponsor ID
- DISON I / VS-0001
- Conditions
- Kidney Stones, Urolithiasis, Nephrolithiasis
- Keywords
- kidney stones, medical device, Urological procedure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Ventaris Surgical IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 20 Jul 2026 (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.
A single-arm, multicenter, international, prospective interventional study designed to evaluate the safety and performance of an investigational device during retrograde intrarenal surgery for the treatment of renal calculi.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational endourological device used during retrograde intrarenal surgery. | Experimental | Device: RIRS with Investigational Device |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of calyceal and/or renal pelvis calculi
- Age from 18 through 85 years
- Maximum stone diameter between 0.5cm - 2.0cm as assessed by Non-Contrast CT scan (≤ 2 mm slice thickness) within 90 days prior to treatment
- Willing and able to comply with all study requirements
- Signs study-specific informed consent form
Key exclusion criteria (21 listed)
- Diagnosis of calculus of the ureter
- BMI ≥ 42
- Significant renal impairment: stage 3a CKD or higher (eGFR <59mL/min)
- Active infection, including urinary tract infection
- Urological anatomic/congenital abnormalities
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 |
|---|---|---|
| RIRS with Investigational DeviceInvestigational endourological device used during retrograde intrarenal surgery. | Device | Investigational endourological device used during retrograde intrarenal surgery. |
Primary outcome
Procedure success
Time frame: Intraoperative
Successful completion of the planned procedure without device-related technical complications.
Serious Adverse Device Effects (SADEs)
Time frame: 30 days post-procedure
Serious adverse device effects related to the investigational device.
Stone-Free Status
Time frame: 30 days post-procedure
Absence of residual stone fragments on CT imaging
7 secondary outcomes
Stone-Free Categories
Time frame: 30 days post-procedure
Intrarenal pressure assessment
Time frame: Intraoperative
Procedure duration
Time frame: Intraoperative
Stone clearance
Time frame: Intraoperative
Residual stone burden
Time frame: 30 days post-procedure
Device- or procedure-related adverse event
Time frame: From procedure to 12 months post-procedure
Stone-related healthcare utilization
Time frame: From procedure to 12 months post-procedure
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 5 Aug 2026.
- Individual participant dataSharing planned: No. IPD will not be shared because this is an early feasibility study involving a small cohort of participants. The data set is limited and may contain information that could risk re-identification. Summary results and aggregate findings will be published following study completion.
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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.
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RIRS with Investigational Device in people with Kidney Stones and Urolithiasis, run by Ventaris Surgical Incorporated at 5 sites in 5 countries.
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 5 inclusion and 21 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: opening soon, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Argentina, Canada, Hong Kong, India, New Zealand. 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 Matt Sprinkel (+1 650 465 6200, matt@ventarissurgical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure success (time frame: Intraoperative). The study lists 3 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 5 Aug 2026.