Stone Clearance
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICELumenis 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.
Sponsors
Lumenis Be Ltd.
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject will be older than 18 years of age 2. Subject was diagnosed with renal calculi meeting the following criteria: * Largest stone measures no more than 2cm on a single diameter and is no less than 0.8cm as defined by X-ray or CT. * Accumulative stone burden (addition of all stone diameters) is no more than 2.5cm. 3. Subject is a candidate for FURS procedure 4. Subject is willing and has signed the Informed Consent Form
Exclusion criteria
1. Subject has undergone a previous treatment for stones in the same kidney 2. Subject requires another, concomitant procedure, other than FURS, to be performed during this treatment session. 3. Female subject is pregnant 4. Concomitant anticoagulant medication that cannot be suspended during surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stone Clearance | Stone clearance based on 1 month follow-up imaging data | stone clearance will be confirmed by CT or X-Ray at 1 month follow up. |
| Post-procedure Catheterization | Post-procedure through hospital discharge; typically discharge occurs on the same day or 1 day post procedure | Post-procedure catheterization by group |
| Procedure Time | during the procedure | Duration (in minutes) of the procedure as an indicator for treatment efficiency. |
| Usage of Alternative Stone Extracting Devices | as measured during the procedure | 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. |
| Hospital Stay | Procedure through hospital discharge | Hospital duration was measured to evaluate treatment efficiency |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Intraoperative Complications | Intraoperative | Number of participants with complications that occur during the procedure. |
| Fiber Transmission | Intraoperative | Fiber transmission (preserving energy transmission during lasing) by group |
| Visibility During Procedure | Intraprocedural | Visibility during procedure by group, rating categories: Poor, Fair, Good, Very Good or Excellent |
| Number of Participants With Occurrence of Retropulsion | Intraoperative | Occurrence of retropulsion by group |
| Ability to Reach Stone Fragments | Intraoperative | Performance rating of ability to reach stone fragments by group |
| Damage to Scope or Fiber | Intraoperative | Damage to scope or fiber by group |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Stone Dusting | Total | Stone Breaking |
|---|---|---|---|
| Age, Continuous | 60.9 years STANDARD_DEVIATION 15.4 | 61.6 years STANDARD_DEVIATION 13.2 | 62.2 years STANDARD_DEVIATION 11.2 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 10 participants | 20 participants | 10 participants |
| Sex: Female, Male Female | 5 Participants | 7 Participants | 2 Participants |
| Sex: Female, Male Male | 5 Participants | 13 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 1 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Hospital Stay
Hospital duration was measured to evaluate treatment efficiency
Time frame: Procedure through hospital discharge
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stone Breaking | Hospital Stay | Same day hospital discharge | 10 Participants |
| Stone Breaking | Hospital Stay | Next day hospital discharge | 0 Participants |
| Stone Dusting | Hospital Stay | Same day hospital discharge | 8 Participants |
| Stone Dusting | Hospital Stay | Next day hospital discharge | 2 Participants |
Primary
Post-procedure Catheterization
Post-procedure catheterization by group
Time frame: Post-procedure through hospital discharge; typically discharge occurs on the same day or 1 day post procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stone Breaking | Post-procedure Catheterization | Ureteric catheter not placed at the end of procedure | 9 Participants |
| Stone Breaking | Post-procedure Catheterization | Ureteric catheter placed at the end of procedure and not removed at hospital discharge | 1 Participants |
| Stone Breaking | Post-procedure Catheterization | Ureteric catheter placed at the end of procedure; removal at hospital discharge unknown | 0 Participants |
| Stone Dusting | Post-procedure Catheterization | Ureteric catheter not placed at the end of procedure | 9 Participants |
| Stone Dusting | Post-procedure Catheterization | Ureteric catheter placed at the end of procedure and not removed at hospital discharge | 0 Participants |
| Stone Dusting | Post-procedure Catheterization | Ureteric catheter placed at the end of procedure; removal at hospital discharge unknown | 1 Participants |
Primary
Procedure Time
Duration (in minutes) of the procedure as an indicator for treatment efficiency.
Time frame: during the procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stone Breaking | Procedure Time | 46.3 Minutes | Standard Deviation 24.8 |
| Stone Dusting | Procedure Time | 36.1 Minutes | Standard Deviation 16.5 |
Primary
Stone Clearance
stone clearance will be confirmed by CT or X-Ray at 1 month follow up.
Time frame: Stone clearance based on 1 month follow-up imaging data
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stone Breaking | Stone Clearance | Complete clearance | 6 Participants |
| Stone Breaking | Stone Clearance | Evidence of fragments not requiring intervention | 3 Participants |
| Stone Breaking | Stone Clearance | Evidence of fragments requiring an additional intervention | 1 Participants |
| Stone Dusting | Stone Clearance | Complete clearance | 6 Participants |
| Stone Dusting | Stone Clearance | Evidence of fragments not requiring intervention | 4 Participants |
| Stone Dusting | Stone Clearance | Evidence of fragments requiring an additional intervention | 0 Participants |
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.
Time frame: as measured during the procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stone Breaking | Usage of Alternative Stone Extracting Devices | Any alternate stone extracting devices used | 0 Participants |
| Stone Breaking | Usage of Alternative Stone Extracting Devices | No alternate stone extracting devices used | 10 Participants |
| Stone Dusting | Usage of Alternative Stone Extracting Devices | Any alternate stone extracting devices used | 1 Participants |
| Stone Dusting | Usage of Alternative Stone Extracting Devices | No alternate stone extracting devices used | 9 Participants |
Secondary
Ability to Reach Stone Fragments
Performance rating of ability to reach stone fragments by group
Time frame: Intraoperative
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stone Breaking | Ability to Reach Stone Fragments | Easily performed | 6 Participants |
| Stone Breaking | Ability to Reach Stone Fragments | Performed well | 4 Participants |
| Stone Breaking | Ability to Reach Stone Fragments | Performed with difficulty | 0 Participants |
| Stone Breaking | Ability to Reach Stone Fragments | Impossible to perform | 0 Participants |
| Stone Dusting | Ability to Reach Stone Fragments | Impossible to perform | 0 Participants |
| Stone Dusting | Ability to Reach Stone Fragments | Easily performed | 9 Participants |
| Stone Dusting | Ability to Reach Stone Fragments | Performed with difficulty | 0 Participants |
| Stone Dusting | Ability to Reach Stone Fragments | Performed well | 1 Participants |
Secondary
Damage to Scope or Fiber
Damage to scope or fiber by group
Time frame: Intraoperative
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Stone Breaking | Damage to Scope or Fiber | Scope damage | Yes | 0 Participants |
| Stone Breaking | Damage to Scope or Fiber | Scope damage | No | 10 Participants |
| Stone Breaking | Damage to Scope or Fiber | Fiber damage | Yes | 0 Participants |
| Stone Breaking | Damage to Scope or Fiber | Fiber damage | No | 10 Participants |
| Stone Dusting | Damage to Scope or Fiber | Fiber damage | No | 10 Participants |
| Stone Dusting | Damage to Scope or Fiber | Scope damage | Yes | 0 Participants |
| Stone Dusting | Damage to Scope or Fiber | Fiber damage | Yes | 0 Participants |
| Stone Dusting | Damage to Scope or Fiber | Scope damage | No | 10 Participants |
Secondary
Fiber Transmission
Fiber transmission (preserving energy transmission during lasing) by group
Time frame: Intraoperative
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stone Breaking | Fiber Transmission | Easily performed | 8 Participants |
| Stone Breaking | Fiber Transmission | Performed well | 2 Participants |
| Stone Breaking | Fiber Transmission | Performed with difficulty | 0 Participants |
| Stone Breaking | Fiber Transmission | Impossible to perform | 0 Participants |
| Stone Dusting | Fiber Transmission | Impossible to perform | 0 Participants |
| Stone Dusting | Fiber Transmission | Easily performed | 9 Participants |
| Stone Dusting | Fiber Transmission | Performed with difficulty | 0 Participants |
| Stone Dusting | Fiber Transmission | Performed well | 1 Participants |
Secondary
Number of Participants With Intraoperative Complications
Number of participants with complications that occur during the procedure.
Time frame: Intraoperative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stone Breaking | Number of Participants With Intraoperative Complications | 0 Participants |
| Stone Dusting | Number of Participants With Intraoperative Complications | 0 Participants |
Secondary
Number of Participants With Occurrence of Retropulsion
Occurrence of retropulsion by group
Time frame: Intraoperative
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stone Breaking | Number of Participants With Occurrence of Retropulsion | Did not occur | 8 Participants |
| Stone Breaking | Number of Participants With Occurrence of Retropulsion | Occurred several times but could be controlled | 2 Participants |
| Stone Breaking | Number of Participants With Occurrence of Retropulsion | Occurred several times and was difficult to control | 0 Participants |
| Stone Breaking | Number of Participants With Occurrence of Retropulsion | Stone lost to retropulsion | 0 Participants |
| Stone Dusting | Number of Participants With Occurrence of Retropulsion | Stone lost to retropulsion | 0 Participants |
| Stone Dusting | Number of Participants With Occurrence of Retropulsion | Did not occur | 10 Participants |
| Stone Dusting | Number of Participants With Occurrence of Retropulsion | Occurred several times and was difficult to control | 0 Participants |
| Stone Dusting | Number of Participants With Occurrence of Retropulsion | Occurred several times but could be controlled | 0 Participants |
Secondary
Visibility During Procedure
Visibility during procedure by group, rating categories: Poor, Fair, Good, Very Good or Excellent
Time frame: Intraprocedural
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stone Breaking | Visibility During Procedure | Fair | 0 Participants |
| Stone Breaking | Visibility During Procedure | Very Good | 7 Participants |
| Stone Breaking | Visibility During Procedure | Poor | 0 Participants |
| Stone Breaking | Visibility During Procedure | Excellent | 3 Participants |
| Stone Breaking | Visibility During Procedure | Good | 0 Participants |
| Stone Dusting | Visibility During Procedure | Excellent | 3 Participants |
| Stone Dusting | Visibility During Procedure | Poor | 0 Participants |
| Stone Dusting | Visibility During Procedure | Fair | 0 Participants |
| Stone Dusting | Visibility During Procedure | Good | 1 Participants |
| Stone Dusting | Visibility During Procedure | Very Good | 6 Participants |