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The purpose of the study is to assess safety and efficacy of a novel steerable ureteral catheter system, the CVAC System for the treatment of urinary stones.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Steerable Ureteroscopic Renal Evacuation (SURE) with the CVAC System | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Steerable Ureteroscopic Renal Evacuation (SURE) with the CVAC System | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Stone Clearance (% Reduction in Stone Volume) | The percent reduction ([Baseline stone volume- 30-Day stone volume] / Baseline stone volume) in stone volume following intervention, observed on non-contrast CT (NCCT) (2.0mm slice thickness). A positive result indicates a decrease in stone volume removed during the procedure; a negative value indicates an increase in stone volume following the procedure. | 30 Days |
| Residual Stone Volume (RSV) | A continuous quantitative measure of remaining stone volume following intervention, observed on non-contrast CT (NCCT) (2.0mm slice thickness). | 30 Days |
| Stone Free Rate (SFR) - Zero Fragments | Where stone free status is defined as zero residual fragments at 30 days observed on non-contrast CT (NCCT) (2.0mm slice thickness). SFR is calculated by determining the number of kidneys in each treatment arm with a stone free status of zero fragments and dividing that by the total number of kidneys treated in the respective treatment arm. | 30 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Muljibhai Patel Urological Hospital | Nadiād | India |
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| ID | Title | Description |
|---|---|---|
| FG000 | Steerable Ureteroscopic Renal Evacuation (SURE) With 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). Steerable Ureteroscopic Renal Evacuation (SURE) with 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Steerable Ureteroscopic Renal Evacuation (SURE) With 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). Steerable Ureteroscopic Renal Evacuation (SURE) with 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). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Stone Clearance (% Reduction in Stone Volume) | The percent reduction ([Baseline stone volume- 30-Day stone volume] / Baseline stone volume) in stone volume following intervention, observed on non-contrast CT (NCCT) (2.0mm slice thickness). A positive result indicates a decrease in stone volume removed during the procedure; a negative value indicates an increase in stone volume following the procedure. | All kidneys available at follow-up were analyzed. | Posted | Mean | Standard Deviation | % stone volume removed | 30 Days | kidneys | kidneys |
|
Index Procedure to Post-op Day-30 (POD30)
Adverse events (AEs) were collected and categorized by the investigators according to the Clavien-Dindo classification system.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Steerable Ureteroscopic Renal Evacuation (SURE) With 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). Steerable Ureteroscopic Renal Evacuation (SURE) with 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection (UTI) | Renal and urinary disorders | Systematic Assessment | Clavien-Dindo Grade II |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jacqueline Welch | Calyxo, Inc. | (925) 526-5900 | info@calyxoinc.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 8, 2023 | Apr 7, 2026 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007669 | Kidney Calculi |
| D052878 | Urolithiasis |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
| kidneys |
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| years |
| Participants |
|
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
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| Stone Density | The highest HU within the kidney | Mean | Standard Deviation | HU | kidneys |
|
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| Total Stone Volume | The total stone volume per kidney | Mean | Standard Deviation | mm^3 | kidneys |
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| Primary | Residual Stone Volume (RSV) | A continuous quantitative measure of remaining stone volume following intervention, observed on non-contrast CT (NCCT) (2.0mm slice thickness). | All kidneys available at follow-up were analyzed. | Posted | Mean | Standard Deviation | mm^3 | 30 Days | kidneys | kidneys |
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|
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| Primary | Stone Free Rate (SFR) - Zero Fragments | Where stone free status is defined as zero residual fragments at 30 days observed on non-contrast CT (NCCT) (2.0mm slice thickness). SFR is calculated by determining the number of kidneys in each treatment arm with a stone free status of zero fragments and dividing that by the total number of kidneys treated in the respective treatment arm. | All kidneys available at follow-up were analyzed. | Posted | Count of Units | kidneys | 30 Days | kidneys | kidneys |
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| 0 |
| 30 |
| 0 |
| 30 |
| 2 |
| 30 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014545 | Urinary Calculi |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |