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The purpose of the study is to compare the effects, good and/or bad, of a treatment for removing kidney stones called the SURE procedure for stone evacuation to the standard treatment using a basket for stone removal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SURE | Active Comparator |
| |
| Standard Ureteroscopy (Basketing) | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SURE | Device | The SURE stone evacuation procedure is a technique intended to more easily and completely remove a kidney stone during a kidney stone treatment. The urologist first uses a laser to break the kidney stone into small pieces. Then with the SURE procedure, the pieces are gently vacuumed out of the kidney instead of retrieving the pieces one-by-one with a basket or leaving them to pass naturally in the urine. Basketing is allowed and might be used with the SURE procedure, if needed to remove some small stones. |
| Measure | Description | Time Frame |
|---|---|---|
| Stone Free Rate (SFR) - Zero Fragments | The primary efficacy endpoint is the SFR, where stone free status is defined as zero residual fragments at 30 days observed on non-contrast CT (NCCT) (1.25mm slice thickness) by blinded central reviewer(s). The SFR is calculated by determining the number of subjects in each treatment arm with a stone free status of zero fragments and dividing that by the total number of subjects treated in the respective treatment arm. | 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Residual Stone Volume (RSV) | A continuous quantitative measure of remaining stone volume following intervention, assessed via post-procedural imaging on NCCT (1.25mm slice thickness) by blinded central reviewer(s). | 30 Days |
| Stone Clearance (% Reduction in Stone Volume) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Phoenix | Arizona | 85054 | United States | ||
| Arizona Institute of Urology |
In total, 132 subject were enrolled and treated. Of the subjects, 123 were randomized. Of these subjects, subjects whose study participation was discontinued prior to the 30-Day CT, who had poor CT quality, major protocol deviations, or who had their procedures aborted were not included in the efficacy analysis. A total of 101 subjects qualified for the efficacy analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | SURE | SURE: The SURE stone evacuation procedure is a technique intended to more easily and completely remove a kidney stone during a kidney stone treatment. The urologist first uses a laser to break the kidney stone into small pieces. Then with the SURE procedure, the pieces are gently vacuumed out of the kidney instead of retrieving the pieces one-by-one with a basket or leaving them to pass naturally in the urine. Basketing is allowed and might be used with the SURE procedure, if needed to remove some small stones. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Jan 26, 2023 |
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| Standard Ureteroscopy (Basketing) | Device | This is a treatment in which the urologist uses a laser to break a kidney stone into small pieces and then uses a tool called a basket to retrieve the pieces one at a time. |
|
Percent reduction ([Baseline stone volume- 30-Day stone volume] / Baseline stone volume) in stone volume following intervention, assessed via post-procedural imaging on NCCT (1.25mm slice thickness) by blinded central reviewer(s). 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 |
| Tucson |
| Arizona |
| 85704 |
| United States |
| Johns Hopkins | Baltimore | Maryland | 21287 | United States |
| New Jersey Urology | Voorhees Township | New Jersey | 08043 | United States |
| Albany Medical College | Albany | New York | 12208 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Prisma Health | Greenville | South Carolina | 29650 | United States |
| Urology Austin | Austin | Texas | 78654 | United States |
| Dell Medical School, The University of Texas at Austin | Austin | Texas | 78712 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Urology of Virginia | Virginia Beach | Virginia | 23462 | United States |
| FG001 | Standard Ureteroscopy (Basketing) | Standard Ureteroscopy (Basketing): This is a treatment in which the urologist uses a laser to break a kidney stone into small pieces and then uses a tool called a basket to retrieve the pieces one at a time. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | SURE | The SURE stone evacuation procedure is a technique intended to more easily and completely remove a kidney stone during a kidney stone treatment. The urologist first uses a laser to break the kidney stone into small pieces. Then with the SURE procedure, the pieces are gently vacuumed out of the kidney instead of retrieving the pieces one-by-one with a basket or leaving them to pass naturally in the urine. Basketing is allowed and might be used with the SURE procedure, if needed to remove some small stones. |
| BG001 | Standard Ureteroscopy (Basketing) | This is a treatment in which the urologist uses a laser to break a kidney stone into small pieces and then uses a tool called a basket to retrieve the pieces one at a time. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Total stone burden | Mean | Standard Deviation | mm |
| |||||||||||||||
| Total stone volume | Mean | Standard Deviation | mm^3 |
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| 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 Free Rate (SFR) - Zero Fragments | The primary efficacy endpoint is the SFR, where stone free status is defined as zero residual fragments at 30 days observed on non-contrast CT (NCCT) (1.25mm slice thickness) by blinded central reviewer(s). The SFR is calculated by determining the number of subjects in each treatment arm with a stone free status of zero fragments and dividing that by the total number of subjects treated in the respective treatment arm. | All patients who met all protocol requirements with no major deviations that compromise the ability to assess primary and secondary endpoints. | Posted | Number | % subjects | 30 Days |
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| Secondary | Residual Stone Volume (RSV) | A continuous quantitative measure of remaining stone volume following intervention, assessed via post-procedural imaging on NCCT (1.25mm slice thickness) by blinded central reviewer(s). | All patients who met all protocol requirements with no major deviations that compromise the ability to assess primary and secondary endpoints. | Posted | Mean | Standard Deviation | mm^3 | 30 Days |
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| Secondary | Stone Clearance (% Reduction in Stone Volume) | Percent reduction ([Baseline stone volume- 30-Day stone volume] / Baseline stone volume) in stone volume following intervention, assessed via post-procedural imaging on NCCT (1.25mm slice thickness) by blinded central reviewer(s). 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 patients who met all protocol requirements with no major deviations that compromise the ability to assess primary and secondary endpoints. | Posted | Mean | Standard Deviation | percent reduction (%) | 30 Days |
|
30 Day
Reporting adverse events per requirements per the Results Data Element Definitions.
Adverse events were assessed in all subjects that were enrolled and treated.
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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 | SURE | The SURE stone evacuation procedure is a technique intended to more easily and completely remove a kidney stone during a kidney stone treatment. The urologist first uses a laser to break the kidney stone into small pieces. Then with the SURE procedure, the pieces are gently vacuumed out of the kidney instead of retrieving the pieces one-by-one with a basket or leaving them to pass naturally in the urine. Basketing is allowed and might be used with the SURE procedure, if needed to remove some small stones. | 0 | 67 | 1 | 67 | 4 | 67 |
| EG001 | Standard Ureteroscopy (Basketing) | Standard Ureteroscopy (Basketing): This is a treatment in which the urologist uses a laser to break a kidney stone into small pieces and then uses a tool called a basket to retrieve the pieces one at a time. | 0 | 65 | 2 | 65 | 5 | 65 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis Requiring Hospitalization | Renal and urinary disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ureteral Damage | Renal and urinary disorders | Systematic Assessment | Clavien-Dindo Grade I |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jacqueline Welch | Calyxo, Inc. | (925) 526-5900 | info@calyxoinc.com |
| Dec 10, 2025 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| D053040 | Nephrolithiasis |
| D052878 | Urolithiasis |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Black or African American |
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| Hispanic/Latino |
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| Asian |
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