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New surgical tool aims to suck away kidney stones faster and safer

NCT ID NCT07712861

Disease control Sponsor: Ventaris Surgical Incorporated Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 20, 2026 · Last updated Aug 06, 2026 · Updated 3 times

Summary

This study tests a new device that combines a camera and suction in one tool for kidney stone removal surgery. About 75 adults with kidney stones between 0.5 and 2.0 cm will undergo the procedure to see if the device safely clears stones and reduces leftover fragments. The goal is to improve surgical outcomes and lower the risk of complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an investigational endourological device that combines suction and optics for kidney stone surgery
What this could lead to
If successful, this device could make kidney stone surgery more efficient by removing stone fragments faster and reducing complications.
What could go wrong
This is a small early pilot study with no control group, so results may not prove the device is better than existing methods. Device-related side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 75 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Diagnosis of calyceal and/or renal pelvis calculi 2. Age from 18 through 85 years 3. 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 4. Willing and able to comply with all study requirements 5. Signs study-specific informed consent form Exclusion Criteria: 1. Diagnosis of calculus of the ureter 2. BMI ≥ 42 3. Significant renal impairment: stage 3a CKD or higher (eGFR \<59mL/min) 4. Active infection, including urinary tract infection 5. Urological anatomic/congenital abnormalities 6. Previous history of struvite stone in the same renal unit 7. Taking anticoagulants that cannot be stopped before and after procedure or known coagulopathy or platelet disorder (except aspirin below 100mg/d) 8. History of gross hematuria 9. Solitary functioning kidney 10. Known allergy to device materials 11. Any severe illness that would prevent complete study participation or confound study results 12. 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. 13. History of open-heart surgery, or cardiac arrest \< 180 days prior to the date of informed consent 14. ASA III or higher 15. Taking systemic immune suppressants 16. Dementia or psychiatric condition that prevents the participant from completing required follow up 17. Contraindication to both general and spinal anesthesia 18. Participating in another investigational study that could affect responses to the study device 19. Unwilling to accept a transfusion should one be required 20. Pregnant or considering getting pregnant within the next 3 months 21. Undergoing bilateral ureteroscopy

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Conditions

The condition(s) this trial relates to.

Kidney Calculi nephrolithiasis urolithiasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Kidney stones Nephrolithiasis Urolithiasis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centre hospitalier de l'Universite de Montreal (CHUM)

    Montreal, Canada

  • Hospital Alemán

    Buenos Aires, Argentina

  • Muljibhai Patel Urological Hospital

    Nadiād, India

  • Tauranga Urology Research Limited

    Tauranga, New Zealand

  • The Chinese University of Hong Kong

    Hong Kong, Hong Kong

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