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| Name | Class |
|---|---|
| Lumenis Be Ltd. | INDUSTRY |
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Twenty (20) subjects presenting with a renal stone and candidates for FURS (flexible ureteroscopic renal surgery) will undergo a single FURS procedure for a kidney stone as part of the study, using the study device. These subjects will be randomized into stone breaking treatment or stone dusting.
This is a randomized, two-arm, prospective, single center study. Subjects will undergo a single flexible ureteroscopic renal surgery (FURS) procedure for a kidney stone as part of this study, using the study device, and will be treated as randomized to either stone breaking treatment or stone dusting treatment. Follow up visits are scheduled for the day of release from the hospital and at 1 month post procedure. Additional treatment sessions, if required, will be at the discretion of the investigator, as part of the site standard of practice. Additional treatment sessions will not be included in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stone breaking | Experimental | Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters. |
|
| Stone dusting | Experimental | Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber | Device | The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation. |
| Measure | Description | Time Frame |
|---|---|---|
| Stone Clearance | stone clearance will be confirmed by CT or X-Ray at 1 month follow up. | Stone clearance based on 1 month follow-up imaging data |
| Post-procedure Catheterization | Post-procedure catheterization by group | Post-procedure through hospital discharge; typically discharge occurs on the same day or 1 day post procedure |
| Procedure Time | Duration (in minutes) of the procedure as an indicator for treatment efficiency. | during the procedure |
| Usage of Alternative Stone Extracting Devices | The need of the surgeon to use baskets, forceps or saline flushing to achieve complete stone clearance. This outcome can influence both procedure time and further complication. | as measured during the procedure |
| Hospital Stay | Hospital duration was measured to evaluate treatment efficiency | Procedure through hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Intraoperative Complications | Number of participants with complications that occur during the procedure. | Intraoperative |
| Visibility During Procedure | Visibility during procedure by group, rating categories: Poor, Fair, Good, Very Good or Excellent |
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Inclusion Criteria:
Subject will be older than 18 years of age
Subject was diagnosed with renal calculi meeting the following criteria:
Subject is a candidate for FURS procedure
Subject is willing and has signed the Informed Consent Form
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clayton Miller | Boston Scientific Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Methodist Hospital | New York | New York | 11215 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stone Breaking | Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters. Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation. |
| FG001 | Stone Dusting | Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters. Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stone Breaking | Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters. Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | stone clearance will be confirmed by CT or X-Ray at 1 month follow up. | Posted | Count of Participants | Participants | Stone clearance based on 1 month follow-up imaging data |
|
Intra-operative to 1 month post-procedure
Adverse event information was collected via assessments at follow-up visits.
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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 | Stone Breaking | Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters. Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | Renal and urinary disorders | Systematic Assessment | Occasional hematuria |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Teri Bird | Boston Scientific | 6123221189 | teri.bird@bsci.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 | Dec 28, 2015 | Sep 26, 2025 | Prot_SAP_000.pdf |
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| Intraprocedural |
| Number of Participants With Occurrence of Retropulsion | Occurrence of retropulsion by group | Intraoperative |
| Ability to Reach Stone Fragments | Performance rating of ability to reach stone fragments by group | Intraoperative |
| Damage to Scope or Fiber | Damage to scope or fiber by group | Intraoperative |
| Fiber Transmission | Fiber transmission (preserving energy transmission during lasing) by group | Intraoperative |
| Stone Dusting |
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters. Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Post-procedure Catheterization | Post-procedure catheterization by group | Posted | Count of Participants | Participants | Post-procedure through hospital discharge; typically discharge occurs on the same day or 1 day post procedure |
|
|
|
| Primary | Procedure Time | Duration (in minutes) of the procedure as an indicator for treatment efficiency. | Posted | Mean | Standard Deviation | Minutes | during the procedure |
|
|
|
| Primary | Usage of Alternative Stone Extracting Devices | The need of the surgeon to use baskets, forceps or saline flushing to achieve complete stone clearance. This outcome can influence both procedure time and further complication. | Posted | Count of Participants | Participants | as measured during the procedure |
|
|
|
| Primary | Hospital Stay | Hospital duration was measured to evaluate treatment efficiency | Posted | Count of Participants | Participants | Procedure through hospital discharge |
|
|
|
| Secondary | Number of Participants With Intraoperative Complications | Number of participants with complications that occur during the procedure. | Posted | Count of Participants | Participants | Intraoperative |
|
|
|
| Secondary | Visibility During Procedure | Visibility during procedure by group, rating categories: Poor, Fair, Good, Very Good or Excellent | Posted | Count of Participants | Participants | Intraprocedural |
|
|
|
| Secondary | Number of Participants With Occurrence of Retropulsion | Occurrence of retropulsion by group | Posted | Count of Participants | Participants | Intraoperative |
|
|
|
| Secondary | Ability to Reach Stone Fragments | Performance rating of ability to reach stone fragments by group | Posted | Count of Participants | Participants | Intraoperative |
|
|
|
| Secondary | Damage to Scope or Fiber | Damage to scope or fiber by group | Posted | Count of Participants | Participants | Intraoperative |
|
|
|
| Secondary | Fiber Transmission | Fiber transmission (preserving energy transmission during lasing) by group | Posted | Count of Participants | Participants | Intraoperative |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Stone Dusting | Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters. Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber: The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation. | 0 | 10 | 0 | 10 | 1 | 10 |
| Other | General disorders | Systematic Assessment | minimal discomfort |
|
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| Ureteric catheter placed at the end of procedure; removal at hospital discharge unknown |
|
| Good |
|
| Very Good |
|
| Excellent |
|
| Occurred several times and was difficult to control |
|
| Stone lost to retropulsion |
|
| Performed with difficulty |
|
| Impossible to perform |
|
| Fiber damage |
|
| Performed with difficulty |
|
| Impossible to perform |
|