Stone clearance with steerable ureteroscopic evacuation compared with other methods

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will prospectively accumulate data from up to 25 sites and up to 250 participants to compare the performance and safety of the CVAC System with SURE and other renal-stone techniques. Patients undergoing ureteroscopy with laser lithotripsy or PCNL may be enrolled and followed per protocol. The study includes multiple wearable and surgical approaches such as CVAC, FANS in flexible ureteroscopy, and direct in-scope suction, as well as traditional ureteroscopy without suction and PCNL to evaluate real-world outcomes. Eligibility requires candidacy for ureteroscopy or PCNL, ability to follow up, and informed consent; exclusion includes active infection, history of sepsis, significant comorbidities, and certain anatomical abnormalities. Lead sponsor is Calyxo, Inc., with sites at University of Miami, Wichita Urology Group, and University at Buffalo.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Candidate for ureteroscopy with laser lithotripsy or PCNL for the treatment of renal stones
* Be willing and able to return for and respond to all study-related follow up procedures
* Have been informed of the nature of the study and has provided informed consent using the IRB approved informed consent (ICF)

Exclusion Criteria:

* Untreated urinary tract infection at the time of the index procedure
* Visual evidence of infection at the time of the index procedure
* History of sepsis
* Significant comorbidities
* Bladder, ureteral or kidney abnormalities
* Pregnant individuals
* Unable to meet the treatment and follow up protocol requirements

Where it's running

• University of Miami
  Miami, Florida, United States Recruiting
• Wichita Urology Group
  Wichita, Kansas, United States Recruiting
• University of Buffalo
  Cheektowaga, New York, United States Recruiting
• Integrated Medical Professionals (IMP)
  New York, New York, United States Recruiting
• Northwell Health
  New York, New York, United States Recruiting
• Urology Specialists of the Carolinas (USOC)
  Charlotte, North Carolina, United States Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Steerable Ureteroscopic Renal Evacuation (SURE) with CVAC vs standard ureteroscopy

  This trial tests whether the SURE system with CVAC can improve outcomes compared with standard ureteroscopy with laser lithotripsy for kidney stones in adult patients.

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• MODULITH SLX-F2 shockwave treatment with StorM-Track versus standard targeting for kidney stones

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  Recruiting Storz Medical AG · Stockholm · NCT07272720

• Comparing robotic and manual methods for treating kidney stones

  This study is testing whether a robotic system works better than traditional manual methods for treating kidney stones to see which approach is safer and more effective for adults.

  Recruiting American University of Beirut Medical Center · Beirut · NCT06996587

• Investigating oxalate production in patients with calcium oxalate kidney stones

  This study is testing if people with calcium oxalate kidney stones produce more oxalate in their bodies than healthy individuals by following a special diet and taking certain supplements.

  Recruiting University of Alabama at Birmingham · Birmingham, Alabama and 1 other locations · NCT06989320

• Acupressure to Ease Pain During ESWL for Kidney Stones

  This study tests whether applying acupressure to specific points before ESWL can reduce pain and improve comfort for adults with kidney or proximal ureteral stones.

  Recruiting Medipol University · Istanbul · NCT07885696

• Audio consent with human voice or AI-voice added to written consent for ureteroscopy

  This study tests if listening to an audio version of the consent form, read by a real urologist or by an AI-cloned voice, helps adults in Turkey understand their ureteroscopy or RIRS consent better than the written form alone.

  Recruiting at 3 sites Aydin Adnan Menderes University · Aydin, Aydın and 2 other locations · NCT07859436

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.