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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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Over 100,000 BPH procedures are performed annually in the US. The purpose of this study is to evaluate the effectiveness of performing MRI guided transrectal laser ablation using a 980 nm laser (VisualaseTM by Medtronic, Inc., a Minnesota, U.S.A. company) to treat benign prostatic hypertrophy (BPH). The laser system will be used to necrotize urological soft tissue within the prostate under MRI guidance. This will be a single center, single arm prospective trial with an anticipated enrollment of 10 men. Patients who elect this treatment option and choose to be part of the study will be enrolled consecutively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FLA for BPH Active Treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI Guided Transrectal Periuretheral Transitional Zone Ablation | Device | Patients will undergo an MRI guided transrectal ablation of tissue within the periuretheral transitional zone. |
| Measure | Description | Time Frame |
|---|---|---|
| International Prostate Symptom Score (IPSS) Change | The IPSS survey rates lower urinary tract symptom severity from 0 (none) to 35 (severe). | From baseline to 2 months |
| International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change | The IPSS QoL question asks patients to rate how they would feel if they were to spend the rest of their lives with their urinary condition just the way it is now, from 0 ("delighted") to 6 ("terrible") | From baseline to 2 months |
| BPH Impact Index Change | This is another survey which rates lower urinary tract symptoms from 0 (none) to 13 (severe) | From baseline to 2 months |
| Sexual Health Inventory of Men (SHIM) Score Change | This survey rates erectile function from 0 (no function) to 25 (full function) | From baseline to 2 months |
| Number of Adverse Events | We asked patients to self-report adverse events. | Continuous until completion of the study at 2 years |
| International Prostate Symptom Score (IPSS) Change | The IPSS survey rates lower urinary tract symptom severity from 0 (none) to 35 (severe). | From baseline to 4 months |
| International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change | The IPSS QoL question asks patients to rate how they would feel if they were to spend the rest of their lives with their urinary condition just the way it is now, from 0 ("delighted") to 6 ("terrible") |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prostate Laser Center, PLLC | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37481065 | Derived | Harman AL, Toth R, Karamanian A. Magnetic Resonance Imaging-Guided Transrectal Prostate Laser Ablation for Benign Prostatic Hyperplasia. J Vasc Interv Radiol. 2023 Nov;34(11):2024-2028. doi: 10.1016/j.jvir.2023.07.015. Epub 2023 Jul 21. No abstract available. |
| Label | URL |
|---|---|
| Related Info | View source |
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All the procedures were performed between May 2017 and May 2018. All procedures were performed at a free-standing magnetic resonance imaging (MRI) center, and pre-procedure and post-procedure visits were completed in an outpatient office.
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| ID | Title | Description |
|---|---|---|
| FG000 | Focal Laser Ablation (FLA) for BPH Active Treatment | MRI Guided Transrectal Periuretheral Transitional Zone Ablation: Patients will undergo an MRI guided transrectal ablation of tissue within the periuretheral transitional zone. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FLA for BPH Active Treatment | MRI Guided Transrectal Periuretheral Transitional Zone Ablation: Patients will undergo an MRI guided transrectal ablation of tissue within the periuretheral transitional zone. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | International Prostate Symptom Score (IPSS) Change | The IPSS survey rates lower urinary tract symptom severity from 0 (none) to 35 (severe). | Posted | Mean | Standard Deviation | units on a scale | From baseline to 2 months |
|
|
2 years
The patients were instructed to self-report their adverse events to us.
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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 | FLA for BPH Active Treatment | MRI Guided Transrectal Periuretheral Transitional Zone Ablation: Patients will undergo an MRI guided transrectal ablation of tissue within the periuretheral transitional zone. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection (UTI) | Renal and urinary disorders | Non-systematic Assessment | Both reported UTIs were lower urinary tract infections, likely related to the foley catheter |
One patient dropped out after 6 month because his symptoms returned and he underwent a TURP.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ara Karamanian, Medical Director of the Prostate Program | Prostate Laser Center, PLLC | (713) 904-4014 | drkaramanian@halodx.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 | Apr 7, 2017 | Aug 2, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| D059411 | Lower Urinary Tract Symptoms |
| D053158 | Nocturia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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|
| From baseline to 4 months |
| BPH Impact Index Change | This is another survey which rates lower urinary tract symptoms from 0 (none) to 13 (severe) | From baseline to 4 months |
| Sexual Health Inventory of Men (SHIM) Score Change | This survey rates erectile function from 0 (no function) to 25 (full function) | From baseline to 4 months |
| International Prostate Symptom Score (IPSS) Change | The IPSS survey rates lower urinary tract symptom severity from 0 (none) to 35 (severe). | From baseline to 6 months |
| International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change | The IPSS QoL question asks patients to rate how they would feel if they were to spend the rest of their lives with their urinary condition just the way it is now, from 0 ("delighted") to 6 ("terrible") | From baseline to 6 months |
| BPH Impact Index Change | This is another survey which rates lower urinary tract symptoms from 0 (none) to 13 (severe) | From baseline to 6 months |
| Sexual Health Inventory of Men (SHIM) Score Change | This survey rates erectile function from 0 (no function) to 25 (full function) | From baseline to 6 months |
| International Prostate Symptom Score (IPSS) Change | The IPSS survey rates lower urinary tract symptom severity from 0 (none) to 35 (severe). | From baseline to 24 months |
| International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change | The IPSS QoL question asks patients to rate how they would feel if they were to spend the rest of their lives with their urinary condition just the way it is now, from 0 ("delighted") to 6 ("terrible") | From baseline to 24 months |
| BPH Impact Index Change | This is another survey which rates lower urinary tract symptoms from 0 (none) to 13 (severe) | From baseline to 24 months |
| Sexual Health Inventory of Men (SHIM) Score Change | This survey rates erectile function from 0 (no function) to 25 (full function) | From baseline to 24 months |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | 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 |
|
| Prostate volume | Prostate volume was calculated by measuring the length, width, and height of the prostate on MRI and using an ellipsoid volume calculation (Ellipsoid volume = L x W x H x π/6). | Mean | Standard Deviation | cubic centimeters (cc) |
|
| International Prostate Symptom Score (IPSS) | Mean | Standard Deviation | points |
|
| International Prostate Symptom Score (IPSS) Quality of Life (QoL) | Mean | Standard Deviation | points |
|
| Benign Prostatic Hyperplasia (BPH) Impact Index | Mean | Standard Deviation | points |
|
| Sexual Health Inventory For Men (SHIM) | Mean | Standard Deviation | points |
|
|
| Primary | International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change | The IPSS QoL question asks patients to rate how they would feel if they were to spend the rest of their lives with their urinary condition just the way it is now, from 0 ("delighted") to 6 ("terrible") | Posted | Mean | Standard Deviation | units on a scale | From baseline to 2 months |
|
|
|
| Primary | BPH Impact Index Change | This is another survey which rates lower urinary tract symptoms from 0 (none) to 13 (severe) | Posted | Mean | Standard Deviation | units on a scale | From baseline to 2 months |
|
|
|
| Primary | Sexual Health Inventory of Men (SHIM) Score Change | This survey rates erectile function from 0 (no function) to 25 (full function) | Posted | Mean | Standard Deviation | score on a scale | From baseline to 2 months |
|
|
|
| Primary | Number of Adverse Events | We asked patients to self-report adverse events. | Two patients experienced urinary tract infections, two patients developed retrograde ejaculation, and one patient had urinary retention after foley catheter removal, requiring catheter replacement and maintenance for 1 week. All adverse events were considered mild using the Society of Interventional Radiology Adverse Events Classification System. | Posted | Count of Participants | Participants | Continuous until completion of the study at 2 years |
|
|
|
| Primary | International Prostate Symptom Score (IPSS) Change | The IPSS survey rates lower urinary tract symptom severity from 0 (none) to 35 (severe). | Posted | Mean | Standard Deviation | units on a scale | From baseline to 4 months |
|
|
|
| Primary | International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change | The IPSS QoL question asks patients to rate how they would feel if they were to spend the rest of their lives with their urinary condition just the way it is now, from 0 ("delighted") to 6 ("terrible") | Posted | Mean | Standard Deviation | units on a scale | From baseline to 4 months |
|
|
|
| Primary | BPH Impact Index Change | This is another survey which rates lower urinary tract symptoms from 0 (none) to 13 (severe) | Posted | Mean | Standard Deviation | units on a scale | From baseline to 4 months |
|
|
|
| Primary | Sexual Health Inventory of Men (SHIM) Score Change | This survey rates erectile function from 0 (no function) to 25 (full function) | Posted | Mean | Standard Deviation | units on a scale | From baseline to 4 months |
|
|
|
| Primary | International Prostate Symptom Score (IPSS) Change | The IPSS survey rates lower urinary tract symptom severity from 0 (none) to 35 (severe). | Posted | Mean | Standard Deviation | units on a scale | From baseline to 6 months |
|
|
|
| Primary | International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change | The IPSS QoL question asks patients to rate how they would feel if they were to spend the rest of their lives with their urinary condition just the way it is now, from 0 ("delighted") to 6 ("terrible") | Posted | Mean | Standard Deviation | units on a scale | From baseline to 6 months |
|
|
|
| Primary | BPH Impact Index Change | This is another survey which rates lower urinary tract symptoms from 0 (none) to 13 (severe) | Posted | Mean | Standard Deviation | units on a scale | From baseline to 6 months |
|
|
|
| Primary | Sexual Health Inventory of Men (SHIM) Score Change | This survey rates erectile function from 0 (no function) to 25 (full function) | Posted | Mean | Standard Deviation | units on a scale | From baseline to 6 months |
|
|
|
| Primary | International Prostate Symptom Score (IPSS) Change | The IPSS survey rates lower urinary tract symptom severity from 0 (none) to 35 (severe). | Posted | Mean | Standard Deviation | units on a scale | From baseline to 24 months |
|
|
|
| Primary | International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change | The IPSS QoL question asks patients to rate how they would feel if they were to spend the rest of their lives with their urinary condition just the way it is now, from 0 ("delighted") to 6 ("terrible") | Posted | Mean | Standard Deviation | units on a scale | From baseline to 24 months |
|
|
|
| Primary | BPH Impact Index Change | This is another survey which rates lower urinary tract symptoms from 0 (none) to 13 (severe) | Posted | Mean | Standard Deviation | units on a scale | From baseline to 24 months |
|
|
|
| Primary | Sexual Health Inventory of Men (SHIM) Score Change | This survey rates erectile function from 0 (no function) to 25 (full function) | Posted | Mean | Standard Deviation | units on a scale | From baseline to 24 months |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 4 |
| 10 |
|
| Retrograde ejaculation | Reproductive system and breast disorders | Non-systematic Assessment | Retrograde ejaculation occurs when semen enters the bladder instead of emerging through the penis during orgasm. |
|
| Urinary retention | Renal and urinary disorders | Non-systematic Assessment | Inability to urinate without difficulty after removal of foley catheter. |
|
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| D052801 |
| Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |