Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology
NCT ID: NCT07101809
Last Updated: 2025-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
150 participants
INTERVENTIONAL
2025-09-30
2029-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard Ureteroscopy (URS)
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.
Standard Ureteroscopy (URS)
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.
Steerable Ureteroscopic Renal Evacuation (SURE) with CVAC System
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).
Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System
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).
Interventions
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Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System
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)
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Significant comorbidities
* Bladder, ureteral or kidney abnormalities
* Pregnant individuals
* Unable to meet the treatment and follow up protocol requirements
18 Years
ALL
No
Sponsors
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Calyxo, Inc.
INDUSTRY
Responsible Party
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Other Identifiers
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CP00006
Identifier Type: -
Identifier Source: org_study_id
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