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To obtain post-market safety and efficacy data for FlexivaTM Pulse High Power Single-Use Laser Fibers during lithotripsy and soft tissue procedure of holmium laser enucleation of the prostate (HoLEP).
Multi-center, open label, prospective study to document on-going post-market safety and performance of Flexiva Pulse High Power Single-Use Laser Fibers.
All subjects meeting the enrollment criteria, signing the consent and undergoing the lithotripsy/HoLEP procedure with the study device(s) will be followed: up to 2 months (60 days) post-discharge from final holmium laser lithotripsy procedure for subjects in the lithotripsy cohort or up to 6 months (180 days + 60 days) post discharge from HoLEP procedure for subjects in the Benign Prostatic Hyperplasia (BPH) cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lithotripsy Cohort | Subjects in this cohort will undergo lithotripsy procedure for the treatment of urinary calculi. |
| |
| Benign Prostatic Hyperplasia (BPH) Cohort | Subjects in this cohort will undergo Holmium Laser Enucleation of the Prostate (HoLEP) procedure for the treatment of BPH. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flexiva Pulse High Power Single-Use Laser Fibers | Device | Flexiva Pulse High Power Single-Use Laser Fibers are intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Serious Adverse Device Effects - Primary Safety Endpoint | The primary safety endpoint is the occurrence of Serious Adverse Device Effects (SADE) related to Flexiva Pulse Laser Fibers during lithotripsy procedures. | Up to 60 days of follow-up for Lithotripsy Cohort |
| Occurrence of Serious Adverse Device Effects - Primary Safety Endpoint | The primary safety endpoint is the occurrence of Serious Adverse Device Effects (SADE) related to Flexiva Pulse Laser Fibers during HoLEP procedures. | Up to 240 days of follow-up for BPH Cohort. |
| Stone Free Rates - Primary Efficacy Endpoint 1 | In lithotripsy procedures: Stone clearance assessed by stone free rates (SFR) at the 1 month follow-up. Stone free was defined as clinically nonsignificant, non-obstructive residual fragments of ≤ 3 mm, asymptomatic, and no auxiliary procedures performed between the final Flexiva Pulse holmium laser lithotripsy procedure and the 1-month follow-up. | 1 month follow-up |
| Change in BPH Symptoms - Primary Efficacy Endpoint 2 | In HoLEP procedures: Improvement in BPH symptoms from baseline as measured by favorable change (decrease) in International Prostate Symptom Score (IPSS) at 3 month follow-up, on a scale of 0 to 35. | 3 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Related AEs and/or ADEs - Secondary Safety Endpoint | Procedure related adverse events and/or adverse device effects related to Flexiva Pulse Laser Fibers, including but not limited to:
| Up to 60 days of follow-up for Lithotripsy Cohort |
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Inclusion Criteria:
For Lithotripsy cohort:
For BPH cohort:
Exclusion Criteria:
For Lithotripsy cohort:
For BPH cohort:
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Approximately 200 subjects will be enrolled and treated for lithotripsy of urinary calculi and BPH indications. There will be about 100 subjects enrolled in the lithotripsy cohort and 100 subjects enrolled in the BPH cohort.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Pheonix | Phoenix | Arizona | 85054 | United States | ||
| University of Miami |
Subjects were considered enrolled in the study after signing and dating the informed consent form and after the lithotripsy/HoLEP procedure was attempted. There was a total of 209 subjects consented and 8 subjects were exited prior to procedure, resulting in a total of 201 subjects enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lithotripsy Cohort | Subjects in this cohort will undergo lithotripsy procedure for the treatment of urinary calculi. Flexiva Pulse High Power Single-Use Laser Fibers: Flexiva Pulse High Power Single-Use Laser Fibers are intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. |
| FG001 | Benign Prostatic Hyperplasia (BPH) Cohort | Subjects in this cohort will undergo Holmium Laser Enucleation of the Prostate (HoLEP) procedure for the treatment of BPH. Flexiva Pulse High Power Single-Use Laser Fibers: Flexiva Pulse High Power Single-Use Laser Fibers are intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Five subjects exited prior to procedure initiation in the Lithotripsy Cohort and 3 subjects exited prior to procedure initiation in the HoLEP cohort. One subject in the Lithotripsy Cohort was withdrawn by investigator after procedure was initiated and no stones were present for use of the Flexiva Pulse Laser Fiber.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lithotripsy Cohort | Subjects in this cohort will undergo lithotripsy procedure for the treatment of urinary calculi. Flexiva Pulse High Power Single-Use Laser Fibers: Flexiva Pulse High Power Single-Use Laser Fibers are intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Occurrence of Serious Adverse Device Effects - Primary Safety Endpoint | The primary safety endpoint is the occurrence of Serious Adverse Device Effects (SADE) related to Flexiva Pulse Laser Fibers during lithotripsy procedures. | The primary analysis was performed for the Intent to Treat (ITT) population. The ITT subject population included all subjects who provided written informed consent to be enrolled into the study and had the lithotripsy procedure attempted. | Posted | Count of Participants | Participants | Up to 60 days of follow-up for Lithotripsy Cohort |
|
Adverse events were collected from the time of index procedure to end of the study for each subject enrolled (up to 60 days post lithotripsy procedure and up to 240 days post HoLEP procedure).
AE reporting included: Serious Adverse Device Effects, Procedure Related Serious Adverse Events, Fatal Serious Adverse Events, Adverse Device Effects, and Procedure Related Adverse Events
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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 | Lithotripsy Cohort | Subjects in this cohort will undergo lithotripsy procedure for the treatment of urinary calculi. Flexiva Pulse High Power Single-Use Laser Fibers: Flexiva Pulse High Power Single-Use Laser Fibers are intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cystitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Winnie Chen | Boston Scientific | 952-930-6000 | FlexivaPulseRegistry@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 | Jul 20, 2021 | Jul 26, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014545 | Urinary Calculi |
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D052878 | Urolithiasis |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Procedure Related AEs and/or ADEs - Secondary Safety Endpoint | Procedure related adverse events and/or adverse device effects related to Flexiva Pulse Laser Fibers, including but not limited to:
| Up to 240 days of follow-up for BPH Cohort. |
| Ability of Fiber to Deliver Energy - Secondary Efficacy Endpoint 1 | For Lithotripsy procedures: • Ability of the laser fiber to deliver energy as measured by whether or not the Lithotripsy procedure was successfully completed as indicated. Tool used will be a yes or no question on the case report form. | Through lithotripsy procedure completion, up to 1 day. |
| Ability of Fiber to Deliver Energy - Secondary Efficacy Endpoint 2 | For HoLEP procedures: Ability of the laser fiber to deliver energy as measured by whether or not the HoLEP procedure was successfully completed as indicated. Tool used will be a yes or no question on the case report form. | Through HoLEP procedure completion, up to 1 day. |
| Fiber and Scope Compatibility - Secondary Efficacy Endpoint 1 | For Lithotripsy procedures: • Compatibility of the laser fiber with endoscope as measured by whether or not the laser fiber is compatible with the endoscope used in the index procedure, including successful passage and maneuverability without fracture. Tool used will be a yes or no question on the case report form. | Through lithotripsy procedure completion, up to 1 day. |
| Fiber and Scope Compatibility - Secondary Efficacy Endpoint 2 | For HoLEP procedures: • Compatibility of the laser fiber with endoscope as measured by whether or not the laser fiber is compatible with the endoscope used in the index procedure, including successful passage and maneuverability without fracture. Tool used will be a yes or no question on the case report form. | Through HoLEP procedure completion, up to 1 day. |
| Change in Uroflowmetry - Secondary Efficacy Endpoint 2 | For HoLEP procedures: • Improvement in uroflowmetry from baseline as measured by change (increase) in maximum urinary flow rate (Qmax) at 3-month follow-up | Up to 3 month follow-up |
| Change in Quality of Life - Secondary Efficacy Endpoint 2 | For HoLEP procedures: Improvement in Quality of Life (QoL) from baseline as measured by favorable change (decrease) in International Prostate Symptom Score (IPSS) at 3-month follow-up, on a scale of 0 to 6. | Up to 3 month follow-up |
| Hemostasis - Secondary Efficacy Endpoint 2 | For HoLEP procedures: • Hemostasis measured by ability to coagulate during HoLEP procedure. Tool used will be a yes or no question on the case report form. | Through HoLEP procedure completion, up to 1 day. |
| Miami |
| Florida |
| 33136 |
| United States |
| AdventHealth Orlando | Orlando | Florida | 32803 | United States |
| Lehigh Valley Hospital | Allentown | Pennsylvania | 18103 | United States |
| Withdrawal by Subject |
|
| Non-study fiber used. |
|
| Protocol Violation |
|
| BG001 |
| Benign Prostatic Hyperplasia (BPH) Cohort |
Subjects in this cohort will undergo Holmium Laser Enucleation of the Prostate (HoLEP) procedure for the treatment of BPH. Flexiva Pulse High Power Single-Use Laser Fibers: Flexiva Pulse High Power Single-Use Laser Fibers are intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
| Primary | Occurrence of Serious Adverse Device Effects - Primary Safety Endpoint | The primary safety endpoint is the occurrence of Serious Adverse Device Effects (SADE) related to Flexiva Pulse Laser Fibers during HoLEP procedures. | The primary analysis was performed for the Intent to Treat (ITT) population. The ITT subject population included all subjects who provided written informed consent to be enrolled into the study and had the HoLEP procedure attempted. | Posted | Count of Participants | Participants | Up to 240 days of follow-up for BPH Cohort. |
|
|
|
|
| Primary | Stone Free Rates - Primary Efficacy Endpoint 1 | In lithotripsy procedures: Stone clearance assessed by stone free rates (SFR) at the 1 month follow-up. Stone free was defined as clinically nonsignificant, non-obstructive residual fragments of ≤ 3 mm, asymptomatic, and no auxiliary procedures performed between the final Flexiva Pulse holmium laser lithotripsy procedure and the 1-month follow-up. | The proportion of subjects who achieved stone clearance at 1 month follow-up post lithotripsy procedure was calculated. The analysis used all available cases and the last available visit data was analyzed if multiple post operative visits occurred. | Posted | Count of Participants | Participants | 1 month follow-up |
|
|
|
|
| Primary | Change in BPH Symptoms - Primary Efficacy Endpoint 2 | In HoLEP procedures: Improvement in BPH symptoms from baseline as measured by favorable change (decrease) in International Prostate Symptom Score (IPSS) at 3 month follow-up, on a scale of 0 to 35. | Change in IPSS total score in BPH subjects from baseline to 3 month post procedure was analyzed. If multiple IPSS scores were collected during the analysis window, only the last IPSS score collected in the window was counted. Visits that occurred from 60 days through 150 days post-operative were considered as 3-month visits. IPSS cannot be obtained in catheterized subjects; 30 subjects had catheters at baseline. 57 subjects had data at both baseline and 3 months post procedure. | Posted | Mean | Standard Deviation | score on a scale | 3 month follow-up |
|
|
|
|
| Secondary | Procedure Related AEs and/or ADEs - Secondary Safety Endpoint | Procedure related adverse events and/or adverse device effects related to Flexiva Pulse Laser Fibers, including but not limited to:
| The analysis was performed for the Intent to Treat (ITT) population. The ITT subject population included all subjects who provided written informed consent to be enrolled into the study and had the lithotripsy procedure attempted. There were no reports of perforations, hemorrhages, or burns in the Lithotripsy cohort. | Posted | Count of Participants | Participants | Up to 60 days of follow-up for Lithotripsy Cohort |
|
|
|
| Secondary | Procedure Related AEs and/or ADEs - Secondary Safety Endpoint | Procedure related adverse events and/or adverse device effects related to Flexiva Pulse Laser Fibers, including but not limited to:
| The analysis was performed for the Intent to Treat (ITT) population. The ITT subject population included all subjects who provided written informed consent to be enrolled into the study and had the lithotripsy procedure attempted. There were no reports of perforations or burns in the BPH cohort; 2 hemorrhages occurred in the ITT population. | Posted | Count of Participants | Participants | Up to 240 days of follow-up for BPH Cohort. |
|
|
|
| Secondary | Ability of Fiber to Deliver Energy - Secondary Efficacy Endpoint 1 | For Lithotripsy procedures: • Ability of the laser fiber to deliver energy as measured by whether or not the Lithotripsy procedure was successfully completed as indicated. Tool used will be a yes or no question on the case report form. | Statistics are based on the number of Flexiva Pulse fibers used in all subjects for which data was available. | Posted | Count of Participants | Participants | Through lithotripsy procedure completion, up to 1 day. |
|
|
|
|
| Secondary | Ability of Fiber to Deliver Energy - Secondary Efficacy Endpoint 2 | For HoLEP procedures: Ability of the laser fiber to deliver energy as measured by whether or not the HoLEP procedure was successfully completed as indicated. Tool used will be a yes or no question on the case report form. | Statistics are based on the number of Flexiva Pulse fibers used in all subjects for which data was available. | Posted | Count of Participants | Participants | Through HoLEP procedure completion, up to 1 day. |
|
|
|
|
| Secondary | Fiber and Scope Compatibility - Secondary Efficacy Endpoint 1 | For Lithotripsy procedures: • Compatibility of the laser fiber with endoscope as measured by whether or not the laser fiber is compatible with the endoscope used in the index procedure, including successful passage and maneuverability without fracture. Tool used will be a yes or no question on the case report form. | Statistics are based on the number of Flexiva Pulse fibers used in all subjects for which data was available. | Posted | Count of Participants | Participants | Through lithotripsy procedure completion, up to 1 day. |
|
|
|
|
| Secondary | Fiber and Scope Compatibility - Secondary Efficacy Endpoint 2 | For HoLEP procedures: • Compatibility of the laser fiber with endoscope as measured by whether or not the laser fiber is compatible with the endoscope used in the index procedure, including successful passage and maneuverability without fracture. Tool used will be a yes or no question on the case report form. | Statistics are based on the number of Flexiva Pulse fibers used in all subjects for which data was available. | Posted | Count of Participants | Participants | Through HoLEP procedure completion, up to 1 day. |
|
|
|
|
| Secondary | Change in Uroflowmetry - Secondary Efficacy Endpoint 2 | For HoLEP procedures: • Improvement in uroflowmetry from baseline as measured by change (increase) in maximum urinary flow rate (Qmax) at 3-month follow-up | The analysis was performed for the Intent to Treat (ITT) population where Qmax was available at baseline and at 3 months post procedure. The ITT subject population included all subjects who provided written informed consent to be enrolled into the study and had the HoLEP procedure attempted. Qmax was available for 58 subjects at both timepoints. | Posted | Mean | Standard Deviation | mL/s | Up to 3 month follow-up |
|
|
|
|
| Secondary | Change in Quality of Life - Secondary Efficacy Endpoint 2 | For HoLEP procedures: Improvement in Quality of Life (QoL) from baseline as measured by favorable change (decrease) in International Prostate Symptom Score (IPSS) at 3-month follow-up, on a scale of 0 to 6. | The primary analysis was performed for the Intent to Treat (ITT) population where the IPSS QoL score was available at baseline and at 3 months post procedure. The ITT subject population included all subjects who provided written informed consent to be enrolled into the study and had the HoLEP procedure attempted. IPSS QoL score was available for 41 subjects at both timepoints. | Posted | Mean | Standard Deviation | score on a scale | Up to 3 month follow-up |
|
|
|
|
| Secondary | Hemostasis - Secondary Efficacy Endpoint 2 | For HoLEP procedures: • Hemostasis measured by ability to coagulate during HoLEP procedure. Tool used will be a yes or no question on the case report form. | The analysis was performed for the Intent to Treat (ITT) population. The ITT subject population included all subjects who provided written informed consent to be enrolled into the study and had the HoLEP procedure attempted. | Posted | Count of Participants | Participants | Through HoLEP procedure completion, up to 1 day. |
|
|
|
|
| 0 |
| 100 |
| 2 |
| 100 |
| 4 |
| 100 |
| EG001 | Benign Prostatic Hyperplasia (BPH) Cohort | Subjects in this cohort will undergo Holmium Laser Enucleation of the Prostate (HoLEP) procedure for the treatment of BPH. Flexiva Pulse High Power Single-Use Laser Fibers: Flexiva Pulse High Power Single-Use Laser Fibers are intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. | 0 | 101 | 6 | 101 | 27 | 101 |
| Urosepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Bladder Stenosis | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Prostatic Haemorrhage | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Blood Loss Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Pyelitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Lower Urinary Tract Symptoms | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Urinary Incontinence | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Bladder Spasm | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Stress Urinary Incontinence | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Erectile Dysfunction | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Pelvic Discomfort | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Device Occlusion | Product Issues | MedDRA | Systematic Assessment |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |