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| Name | Class |
|---|---|
| Lumenis Be Ltd. | INDUSTRY |
Twenty (20) subjects presenting with a hyperplasia enlarged prostate and candidates for surgery will undergo a single treatment for ablation of the prostate using the study device. Follow up visits are scheduled for the day of release from the hospital and at 1 and 3 months post procedure.
The primary objective of this study is to explore Vaporization efficacy and safety when treating BPH (Benign prostatic hyperplasia) with the contact side firing fiber with recommended settings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ablation of the prostate | Experimental | ablation of the prostate will be performed using the study device: Lumenis Pulse P120H Holmium Laser |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumenis Pulse P120H and Xpeeda side firing fiber | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ablation Time | Calculate the lasing time (in minutes) to ablate the prostate as an indication for treatment efficiency. | Intraprocedural (procedure time is typically 1 to 3 hours) |
| Ablation Rate | Ablation rate is the change in prostate volume measured by trans-rectal ultrasound divided by the procedure time. Ablation rate= (baseline prostate volume - 3-Month prostate volume in mL) / Procedure time in minutes | Baseline and 3-month follow-up visit |
| Efficiency of the Laser to Ablate the Prostate | Ablation efficiency is the change in prostate volume, as measured by trans-urethral ultrasound, between baseline and the 3-month follow-up visit divided by energy. Efficiency = (Baseline prostate volume in mL - prostate volume at the 3-month follow-up visit) / energy in J | Baseline and 3-month follow-up visit |
| Safety: Intraoperative Complications | Number and type of intraoperative complications | Intraoperative (procedure time is typically 1 to 3 hours) |
| Safety: Perioperative Complications | Number of Re-Catheterizations and number of Readmissions were evaluated within this Outcome Measure. Erectile Dysfunction is reported separately. Other complications with reporting of Level of Severity (mild, moderate, or severe) are listed as part of this Outcome Measure. These other complications were Bleeding, Dysuria, Hematuria, Urgency, Urinary Incontinence, Urinary Retention, Frequency, and Nocturia | Post-procedure through 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Erectile Dysfunction | Sum score of International Index of Erectile Function (IIEF-5) questionnaire which measures erectile function, orgasmic function, sexual desire, and satisfaction. Each question is ranked 1-5 with a total sum score of 5 (severe erectile dysfunction) to 25 (normal function). | Baseline and 3-month follow-up visit |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 | Ablation of the Prostate | ablation of the prostate will be performed using the study device: Lumenis Pulse P120H Holmium Laser Lumenis Pulse P120H and Xpeeda side firing fiber |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ablation of the Prostate | ablation of the prostate will be performed using the study device: Lumenis Pulse P120H Holmium Laser Lumenis Pulse P120H and Xpeeda side firing fiber |
| 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 | Ablation Time | Calculate the lasing time (in minutes) to ablate the prostate as an indication for treatment efficiency. | Posted | Mean | Standard Deviation | Minutes | Intraprocedural (procedure time is typically 1 to 3 hours) |
|
|
3 months
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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 | Ablation of the Prostate | ablation of the prostate will be performed using the study device: Lumenis Pulse P120H Holmium Laser Lumenis Pulse P120H and Xpeeda side firing fiber |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urgency | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Program Manager | Boston Scientific | 612-322-1189 | 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 | Jun 2, 2016 | Sep 26, 2025 | Prot_SAP_000.pdf |
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| Visibility During Procedure |
Rating on a scale of 1 (Poor) to 5 (Excellent) of the visibility during the procedure |
| Intraprocedural (procedure time is typically 1 to 3 hours) |
| Number of Fibers Used During Procedure | Number of fibers used during the BPH procedure | Intraprocedural (procedure time is typically 1 to 3 hours) |
| Catheterization Time | Number of days catheter was in place post-ablation of the prostate | Postoperatively through study completion up to 3 months |
| Hospital Stay Duration | Number of days in hospital | Procedure through discharge from hospital (typically 1 day, but measured through end of study up to 3 months) |
| International Prostate Symptom Score Quality of Life | The International Prostate Symptom Score (IPSS) is an eight-question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the lower urinary tract symptoms of benign prostatic hyperplasia (BPH). The Quality of Life question has a scale of 0-6, with 0=delighted and 6=terrible. | Baseline, 1-month and 3-month follow-up visits |
| Qmax Uroflow | The maximum urine flow rate (Qmax) is a measure of the quantity of urine excreted in a specified period of time, expressed in cubic centimeters/second (cc/sec). | Baseline, 1-month and 3-month follow-up visits |
| PVR (Post-void Residual) | Volume of urine remaining in the bladder after voiding, measured via ultrasound | Baseline, 1-month and 3-month follow-up visits |
| PSA (Prostate-specific Antigen) | Prostate-specific antigen, or PSA, is a protein produced by cells of the prostate gland. Prostate cancer can cause elevated PSA levels. | Baseline and 3-month follow-up visit |
| Americal Urological Association (AUA) Symptom Index | The American Urological Association (AUA) Symptom Index assesses the severity of lower urinary tract symptoms in men, particularly related to benign prostatic hyperplasia. The AUA Symptom Score ranges from 0 to 35, with higher scores indicating more severe urinary symptoms related to benign prostatic hyperplasia (BPH). | Baseline, 1-month and 3-month follow-up visits |
| 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 | Ablation Rate | Ablation rate is the change in prostate volume measured by trans-rectal ultrasound divided by the procedure time. Ablation rate= (baseline prostate volume - 3-Month prostate volume in mL) / Procedure time in minutes | Posted | Mean | Standard Deviation | mL/minutes | Baseline and 3-month follow-up visit |
|
|
|
| Primary | Efficiency of the Laser to Ablate the Prostate | Ablation efficiency is the change in prostate volume, as measured by trans-urethral ultrasound, between baseline and the 3-month follow-up visit divided by energy. Efficiency = (Baseline prostate volume in mL - prostate volume at the 3-month follow-up visit) / energy in J | Posted | Mean | Standard Deviation | mL/Joules | Baseline and 3-month follow-up visit |
|
|
|
| Primary | Safety: Intraoperative Complications | Number and type of intraoperative complications | Posted | Number | number of events | Intraoperative (procedure time is typically 1 to 3 hours) |
|
|
|
| Primary | Safety: Perioperative Complications | Number of Re-Catheterizations and number of Readmissions were evaluated within this Outcome Measure. Erectile Dysfunction is reported separately. Other complications with reporting of Level of Severity (mild, moderate, or severe) are listed as part of this Outcome Measure. These other complications were Bleeding, Dysuria, Hematuria, Urgency, Urinary Incontinence, Urinary Retention, Frequency, and Nocturia | All patients were assessed post-procedurally through the 3-month follow-up visit for number of Re-Catheterizations, Readmissions and other complications including Bleeding, Dysuria, Hematuria, Urgency, Urinary Incontinence, Urinary Retention, Frequency, and Nocturia. | Posted | Number | Events | Post-procedure through 3 months | Specific intraoperative complications | Specific intraoperative complications |
|
|
|
| Secondary | Erectile Dysfunction | Sum score of International Index of Erectile Function (IIEF-5) questionnaire which measures erectile function, orgasmic function, sexual desire, and satisfaction. Each question is ranked 1-5 with a total sum score of 5 (severe erectile dysfunction) to 25 (normal function). | 19 participants had evaluable data at baseline, and 16 participants had evaluable data from the 3-month follow-up visit | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3-month follow-up visit |
|
|
|
| Secondary | Visibility During Procedure | Rating on a scale of 1 (Poor) to 5 (Excellent) of the visibility during the procedure | Posted | Count of Participants | Participants | Intraprocedural (procedure time is typically 1 to 3 hours) |
|
|
|
| Secondary | Number of Fibers Used During Procedure | Number of fibers used during the BPH procedure | Posted | Count of Participants | Participants | Intraprocedural (procedure time is typically 1 to 3 hours) |
|
|
|
| Secondary | Catheterization Time | Number of days catheter was in place post-ablation of the prostate | Posted | Count of Participants | Participants | Postoperatively through study completion up to 3 months |
|
|
|
| Secondary | Hospital Stay Duration | Number of days in hospital | Posted | Count of Participants | Participants | Procedure through discharge from hospital (typically 1 day, but measured through end of study up to 3 months) |
|
|
|
| Secondary | International Prostate Symptom Score Quality of Life | The International Prostate Symptom Score (IPSS) is an eight-question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the lower urinary tract symptoms of benign prostatic hyperplasia (BPH). The Quality of Life question has a scale of 0-6, with 0=delighted and 6=terrible. | 20 participants, 17 participants, and 18 participants had evaluable data at baseline, 1-month, and 3-month follow-up visits, respectively. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1-month and 3-month follow-up visits |
|
|
|
| Secondary | Qmax Uroflow | The maximum urine flow rate (Qmax) is a measure of the quantity of urine excreted in a specified period of time, expressed in cubic centimeters/second (cc/sec). | 20 participants had evaluable data at baseline. 17 participants and 19 participants had evaluable data from the 1-month and 3-month follow-up visits, respectively. | Posted | Mean | Standard Deviation | cc/sec | Baseline, 1-month and 3-month follow-up visits |
|
|
|
| Secondary | PVR (Post-void Residual) | Volume of urine remaining in the bladder after voiding, measured via ultrasound | 20 participants had evaluable data at baseline and the 1-month follow-up visit. 19 participants had evaluable data at the 3-month follow-up visit. | Posted | Mean | Standard Deviation | mL | Baseline, 1-month and 3-month follow-up visits |
|
|
|
| Secondary | PSA (Prostate-specific Antigen) | Prostate-specific antigen, or PSA, is a protein produced by cells of the prostate gland. Prostate cancer can cause elevated PSA levels. | 15 participants and 19 participants had evaluable data at the baseline and 3-month interval, respectively. | Posted | Mean | Standard Deviation | ng/mL | Baseline and 3-month follow-up visit |
|
|
|
| Secondary | Americal Urological Association (AUA) Symptom Index | The American Urological Association (AUA) Symptom Index assesses the severity of lower urinary tract symptoms in men, particularly related to benign prostatic hyperplasia. The AUA Symptom Score ranges from 0 to 35, with higher scores indicating more severe urinary symptoms related to benign prostatic hyperplasia (BPH). | 20, 17, and 20 participants had evaluable data at baseline, 1-month and 3-month follow-up visits, respectively. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1-month and 3-month follow-up visits |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 12 |
| 20 |
| Urinary Incontinence | Renal and urinary disorders | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | Systematic Assessment |
|
| Bleeding | Renal and urinary disorders | Systematic Assessment |
|
| Other | Renal and urinary disorders | Systematic Assessment | Frequency, mild |
|
| Other | Renal and urinary disorders | Systematic Assessment | Mild nocturia |
|
| Other | Renal and urinary disorders | Systematic Assessment | "Failed TOV POD #1, foley placed easily for outpatient D/C." |
|
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| Bleeding - occurred several times but could be controlled |
|
| Blood transfusion |
|
| Title | Measurements |
|---|---|
|
| Urinary retention (mild) at 1 month post procedure |
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| Urinary retention (moderate) at 1 month post procedure |
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| Peri-procedure Urgency (mild) |
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| Urgency (mild) at 1 month |
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| Urgency (mild) at 3 months |
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| Urinary Incontinence (mild) at 1 month |
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| Dysuria (mild) at 1 month |
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| Dysuria (mild) at 3 months |
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| Peri-procedure Hematuria (mild) |
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| Hematuria (mild) at 3 months post procedure |
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| Bleeding (mild) at hospital discharge |
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| Bleeding (mild) at 1 month post procedure |
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| Frequency (mild) 1 month post procedure |
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| Frequency (mild) 3 months post procedure |
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| Nocturia (mild) 1 month post procedure |
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| Nocturia (mild) 3 months post procedure |
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| Excellent |
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| 3-Month Follow-up |
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| 3-month follow-up visit |
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| 3-month follow-up visit |
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| 3-month follow-up visit |
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