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A real world study to evaluate the feasibility, preliminary safety and performance of Rezūm system in BPH treatment in China Rezūm RWS study
This RWS study is to evaluate the feasibility, preliminary safety and performance of Rezūm system in BPH treatment in China, to generate local real world data from a Chinese BPH population.
The Rezūm System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH. It is indicated for men ≥50 years of age with a prostate volume ≥ 30cm3 and ≤80cm3. The Rezūm System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rezūm system | The basic principle of the Rezūm System is to deliver a controlled amount of sterile water vapor directly into the hyperplastic tissue in the transition zone of the prostate using a transurethral approach .The stored thermal energy in the vapor is transferred directly onto the cell membranes as the vapor condenses and releases the heat of condensation, causing cell death. Inaddition, this thermal energy transfer collapses the vasculature within the treatment zone, resulting in a bloodless procedure. During procedure the water vapor is created by a heating element in the Rezūm Delivery Device,Saline flush during vapor delivery protects and preserves the urethra. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rezūm System | Device | The basic principle of the Rezūm System is to deliver a controlled amount of sterile water vapor directly into the hyperplastic tissue in the transition zone of the prostate using a transurethral approach .The stored thermal energy in the vapor is transferred directly onto the cell membranes as the vapor condenses and releases the heat of condensation, causing cell death. Inaddition, this thermal energy transfer collapses the vasculature within the treatment zone, resulting in a bloodless procedure. During procedure the water vapor is created by a heating element in the Rezūm Delivery Device,Saline flush during vapor delivery protects and preserves the urethra. |
| Measure | Description | Time Frame |
|---|---|---|
| International Prostate Symptom Score (IPSS) Change From Baseline to the Last Follow-up Date, Anywhere Between Month 3 - Month 6 Post Rezūm Procedure. | International prostate symptom score (IPSS) is a questionnaire used to indicate the severity of LUTS symptoms, There are 7 questions relating to different symptoms subjects be experiencing. 7 questions about patients' urinating include Incomplete emptying, Frequency, Intermittency, Urgency, Weak stream, Straining and Nocturia, every question have 0-5 scores according to Prostate Symptom, the higher score mean patient have more severe the symptoms. IPSS total score: the minimum score is 0 and maximum score are 35. IPSS total 0-7 scores are mild symptoms, IPSS total 8-19 scores are moderate symptoms and IPSS total 20-35 scores are severe symptoms The change was the value at the baseline minus the value at last follow-up date, anywhere between month 3 - month 6 minus | from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezūm procedure |
| Device Related Serious Complications From Rezūm Procedure to the Last Follow-up Date, Anywhere Between Month 3 - Month 6 Post Rezūm Procedure. | Composite device related serious complications for this endpoint are defined as:
| from Rezūm procedure to the last follow-up date, anywhere between month 3 - month 6 post Rezūm procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Rezūm Procedure Time | Rezūm procedure time is refers to the urethral entry of the catheter by Rezūm and exit after the ablation of the catheter by Rezūm | During Rezūm procedure |
| Length of Catheterization |
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Inclusion Criteria:
Exclusion Criteria:
The Rezūm System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH
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Up to 30 subjects who were diagnosed as BPH and treated with Rezūm system will be collected to get 22 treated subjects with valid data.
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| Name | Affiliation | Role |
|---|---|---|
| Ming Liu, Dr | Boao Yiling Life Care Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boao Yiling Life Care Center | Boao | Hainan | 571437 | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rezūm System | Rezūm System: The basic principle of the Rezūm System is to deliver a controlled amount of sterile water vapor directly into the hyperplastic tissue in the transition zone of the prostate using a transurethral approach .The stored thermal energy in the vapor is transferred directly onto the cell membranes as the vapor condenses and releases the heat of condensation, causing cell death. Inaddition, this thermal energy transfer collapses the vasculature within the treatment zone, resulting in a bloodless procedure. During procedure the water vapor is created by a heating element in the Rezūm Delivery Device,Saline flush during vapor delivery protects and preserves the urethra. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rezūm System | Rezūm System: The basic principle of the Rezūm System is to deliver a controlled amount of sterile water vapor directly into the hyperplastic tissue in the transition zone of the prostate using a transurethral approach .The stored thermal energy in the vapor is transferred directly onto the cell membranes as the vapor condenses and releases the heat of condensation, causing cell death. Inaddition, this thermal energy transfer collapses the vasculature within the treatment zone, resulting in a bloodless procedure. During procedure the water vapor is created by a heating element in the Rezūm Delivery Device,Saline flush during vapor delivery protects and preserves the urethra. |
| 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 From Baseline to the Last Follow-up Date, Anywhere Between Month 3 - Month 6 Post Rezūm Procedure. | International prostate symptom score (IPSS) is a questionnaire used to indicate the severity of LUTS symptoms, There are 7 questions relating to different symptoms subjects be experiencing. 7 questions about patients' urinating include Incomplete emptying, Frequency, Intermittency, Urgency, Weak stream, Straining and Nocturia, every question have 0-5 scores according to Prostate Symptom, the higher score mean patient have more severe the symptoms. IPSS total score: the minimum score is 0 and maximum score are 35. IPSS total 0-7 scores are mild symptoms, IPSS total 8-19 scores are moderate symptoms and IPSS total 20-35 scores are severe symptoms The change was the value at the baseline minus the value at last follow-up date, anywhere between month 3 - month 6 minus | Posted | Median | Standard Deviation | scores on a scale | from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezūm procedure |
|
Adverse event data were collected in 6 months post Rezūm procedure
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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 | Rezūm System | The basic principle of the Rezūm System is to deliver a controlled amount of sterile water vapor directly into the hyperplastic tissue in the transition zone of the prostate using a transurethral approach .The stored thermal energy in the vapor is transferred directly onto the cell membranes as the vapor condenses and releases the heat of condensation, causing cell death. Inaddition, this thermal energy transfer collapses the vasculature within the treatment zone, resulting in a bloodless procedure. During procedure the water vapor is created by a heating element in the Rezūm Delivery Device,Saline flush during vapor delivery protects and preserves the urethra. Rezūm System: The basic principle of the Rezūm System is to deliver a controlled amount of sterile water vapor directly into the hyperplastic tissue in the transition zone of the prostate using a transurethral approach .The stored thermal energy in the vapor is transferred directly onto the cell membranes as the vapor condenses and releases the heat of condensation, causing cell death. Inaddition, this thermal energy transfer collapses the vasculature within the treatment zone, resulting in a bloodless procedure. During procedure the water vapor is created by a heating element in the Rezūm Delivery Device,Saline flush during vapor delivery protects and preserves the urethra. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urethral disorder | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ming Liu | Boao Yiling Life Care Center | 139 1103 6970 | +86 | liuming9876@yeah.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 22, 2021 | Oct 11, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 17, 2021 | Nov 29, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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|
Length of Catheterization is the date from date of catheter implantation to date of catheter removal
| 1 month post Rezum procedure |
| The Change of Peak Flow Rate (Qmax) From Baseline to the Last Follow-up Date, Anywhere Between Month 3 - Month 6 Post Rezūm Procedure. | The change of Peak Flow Rate (Qmax) from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezūm procedure. Which are the value at the last follow-up date, anywhere between month 3 - month 6 minus value at baseline | from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezūm procedure. |
| Post Void Residual Urine Volume (PVR） | The change of Post Void Residual Urine Volume (PVR）from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezūm procedure. The change are the baseline value minus the value at the last follow-up date, anywhere between month 3 - month 6 minus. | from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezūm procedure. |
| Quality of Life (Qol) | The change of Quality of Life from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezum procedure. There is only 1 question about Quality of life due to urinary symptoms which is 'If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?' This question have 0-6 scores according to patient's satisfaction about Quality of Life, the higher score mean patient have poor satisfaction. The change was the baseline value minus the value at the last follow-up date, anywhere between month 3 - month 6. | from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezum procedure |
| Ejective Function (MSHQ-EjD) | The change of Ejective function-Male Sexual Health Questionnaire Short Form- Ejaculation dysfunction（MSHQ-EjD ) from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezum procedure. Ejective function (MSHQ-EjD) is a questionnaire used to assess the ejective function. There are 4 questions relating to Ejaculation dysfunction which need patients to answer. 3 questions about patients' ejective function assessing include completion of ejaculation, Strength of ejaculation and Volume of semen when ejaculation. Every question have 0-5 scores according to assessing the ejective function, the lower score mean patient have more severe the ejective function. MSHQ-EjD total score: the minimum score is 0 and maximum score are 15. The change are the value at the last follow-up date, anywhere between month 3 - month 6 minus value at baseline | from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezum procedure |
| The Change of International Index of Erectile Function(IIEF) From Baseline to the Last Follow-up Date, Anywhere Between Month 3 - Month 6 | The change of the International Index of Erectile Function(IIEF) from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezum procedure. Erectile Function(IIEF) is a questionnaire used to assess the Sexual Health Inventory of men. There are 5 questions relating to Erectile Function which need patients to answer. Every question have 0-5 scores, the lower score mean patient have more severe the Erectile Function. The IIEF-5 is administered as a screening instrument for the presence & severity of ED in conjunction with the clinical assessment. The score is the sun of the responses to the five items, so that overall score may range from 0 to 25. A score of 20 or higher indicates a normal degree of erectile functioning. Low scores (10 or less) indicate moderate to severe ED. The change are the value at the last follow-up date, anywhere between month 3 - month 6 minus value at baseline | From baseline to the last follow-up date, anywhere between month 3 - month 6 |
| Participants |
|
| Age, Continuous | Median | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Weight | Median | Standard Deviation | Kg |
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| Prostate Volume (cm^3) | Median | Standard Deviation | cm3 |
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| Peak flow rate (Qmax)) | Median | Standard Deviation | mL/second |
|
| Rezūm System |
The basic principle of the Rezūm System is to deliver a controlled amount of sterile water vapor directly into the hyperplastic tissue in the transition zone of the prostate using a transurethral approach .The stored thermal energy in the vapor is transferred directly onto the cell membranes as the vapor condenses and releases the heat of condensation, causing cell death. Inaddition, this thermal energy transfer collapses the vasculature within the treatment zone, resulting in a bloodless procedure. During procedure the water vapor is created by a heating element in the Rezūm Delivery Device,Saline flush during vapor delivery protects and preserves the urethra. Rezūm System: The basic principle of the Rezūm System is to deliver a controlled amount of sterile water vapor directly into the hyperplastic tissue in the transition zone of the prostate using a transurethral approach .The stored thermal energy in the vapor is transferred directly onto the cell membranes as the vapor condenses and releases the heat of condensation, causing cell death. Inaddition, this thermal energy transfer collapses the vasculature within the treatment zone, resulting in a bloodless procedure. During procedure the water vapor is created by a heating element in the Rezūm Delivery Device,Saline flush during vapor delivery protects and preserves the urethra. |
|
|
| Primary | Device Related Serious Complications From Rezūm Procedure to the Last Follow-up Date, Anywhere Between Month 3 - Month 6 Post Rezūm Procedure. | Composite device related serious complications for this endpoint are defined as:
| Posted | Number | adverse events | from Rezūm procedure to the last follow-up date, anywhere between month 3 - month 6 post Rezūm procedure. |
|
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| Secondary | Rezūm Procedure Time | Rezūm procedure time is refers to the urethral entry of the catheter by Rezūm and exit after the ablation of the catheter by Rezūm | Posted | Median | Standard Deviation | Minutes | During Rezūm procedure |
|
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| Secondary | Length of Catheterization | Length of Catheterization is the date from date of catheter implantation to date of catheter removal | Posted | Median | Standard Deviation | days | 1 month post Rezum procedure |
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| Secondary | The Change of Peak Flow Rate (Qmax) From Baseline to the Last Follow-up Date, Anywhere Between Month 3 - Month 6 Post Rezūm Procedure. | The change of Peak Flow Rate (Qmax) from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezūm procedure. Which are the value at the last follow-up date, anywhere between month 3 - month 6 minus value at baseline | Only 11 subjects completed Qmax in 3-6 months | Posted | Median | Standard Deviation | mL/second | from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezūm procedure. |
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| Secondary | Post Void Residual Urine Volume (PVR） | The change of Post Void Residual Urine Volume (PVR）from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezūm procedure. The change are the baseline value minus the value at the last follow-up date, anywhere between month 3 - month 6 minus. | Only 15 subjects completed PVR test in 3-6 month. | Posted | Median | Standard Deviation | ml | from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezūm procedure. |
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| Secondary | Quality of Life (Qol) | The change of Quality of Life from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezum procedure. There is only 1 question about Quality of life due to urinary symptoms which is 'If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?' This question have 0-6 scores according to patient's satisfaction about Quality of Life, the higher score mean patient have poor satisfaction. The change was the baseline value minus the value at the last follow-up date, anywhere between month 3 - month 6. | Only 20 subjects completed Quality of Life testing in 3-6 months post Rezum procedure. | Posted | Median | Standard Deviation | scores on a scale | from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezum procedure |
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| Secondary | Ejective Function (MSHQ-EjD) | The change of Ejective function-Male Sexual Health Questionnaire Short Form- Ejaculation dysfunction（MSHQ-EjD ) from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezum procedure. Ejective function (MSHQ-EjD) is a questionnaire used to assess the ejective function. There are 4 questions relating to Ejaculation dysfunction which need patients to answer. 3 questions about patients' ejective function assessing include completion of ejaculation, Strength of ejaculation and Volume of semen when ejaculation. Every question have 0-5 scores according to assessing the ejective function, the lower score mean patient have more severe the ejective function. MSHQ-EjD total score: the minimum score is 0 and maximum score are 15. The change are the value at the last follow-up date, anywhere between month 3 - month 6 minus value at baseline | Only 18 subjects completed Ejective function assessment | Posted | Median | Standard Deviation | scores on a scale | from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezum procedure |
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| Secondary | The Change of International Index of Erectile Function(IIEF) From Baseline to the Last Follow-up Date, Anywhere Between Month 3 - Month 6 | The change of the International Index of Erectile Function(IIEF) from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezum procedure. Erectile Function(IIEF) is a questionnaire used to assess the Sexual Health Inventory of men. There are 5 questions relating to Erectile Function which need patients to answer. Every question have 0-5 scores, the lower score mean patient have more severe the Erectile Function. The IIEF-5 is administered as a screening instrument for the presence & severity of ED in conjunction with the clinical assessment. The score is the sun of the responses to the five items, so that overall score may range from 0 to 25. A score of 20 or higher indicates a normal degree of erectile functioning. Low scores (10 or less) indicate moderate to severe ED. The change are the value at the last follow-up date, anywhere between month 3 - month 6 minus value at baseline | Posted | Median | Standard Deviation | scores on a scale | From baseline to the last follow-up date, anywhere between month 3 - month 6 |
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| 0 |
| 22 |
| 0 |
| 22 |
| 22 |
| 22 |
| Haematuria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| D052801 |
| Male Urogenital Diseases |