What this study is
The goal of this clinical trial is to compare Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System and standard ureteroscopy (URS) with laser lithotripsy for the treatment of urolithiasis. This is a prospective, randomized (1:1), multi-center study.
What's being tested
- Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System
Intervention · DEVICE
The CVAC Aspiration System is a sterile, single use, steerable ureteral catheter system with integrated vision, irrigation and aspiration for the treatment and removal of urinary stones (kidney stones, fragments, and dust).
- Standard Ureteroscopy (URS)
Intervention · DEVICE
Arm Description: This is a treatment in which the urologist uses a laser to break a kidney stone into very small pieces and then places a tool called a stent to allows the remaining pieces to fall out.
Study details
- Official title
- Evaluating the Safety and Effectiveness of Steerable Ureteroscopic Renal Evacuation (SURE) With the CVAC® System Compared to Standard Ureteroscopy With no Suction for the Treatment of Renal Stones: a Prospective, Randomized Trial
- Sponsor
- Calyxo, Inc.
- Conditions
- Urolithiasis · Stones, Kidney · Renal Stones · Kidney Stones
- Enrolling
- 150 people
- Starts
- 2026-05-21
- Est. completion
- 2029-07
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Candidate for ureteroscopy with laser lithotripsy
- 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)
You can't join if
- Untreated urinary tract infection at the time of the index procedure
- Significant comorbidities
- Bladder, ureteral or kidney abnormalities
- Pregnant individuals
- Unable to meet the treatment and follow up protocol requirements
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (6)
6 openThe University of Alabama at Birmingham
Birmingham, Alabama, United States
- Samuel P. Dransfield, MS · Contact205-641-6620sdransfield@uabmc.edu
RecruitingUniversity of Florida
Gainesville, Florida, United States
- John Marks · Contact352-273-5618marksjg@ufl.edu
RecruitingIcahn School of Medicine at Mount Sinai
New York, New York, United States
- Monali Fatterpekar, PhD · Contact212-241-0751monali.fatterpekar@mountsinai.org
RecruitingOhioHealth Research Institute
Columbus, Ohio, United States
- Aubrey Steele · Contact614-788-3542Aubrey.Steele@ohiohealth.com
RecruitingMidLantic Urology
Bala-Cynwyd, Pennsylvania, United States
- Cheryl Zinar, RN, BSN · Contact610-667-0458 ext. Opt. 2czinar@midlanticurology.com
RecruitingThe University of Texas at Austin, Dell Medical School
Austin, Texas, United States
- Swetha Venkataraman · Contact512-495-2201swetha.venkataraman@austin.utexas.edu
Recruiting
Study team
Sponsor
Calyxo, Inc.
Study ID CP00006
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.