An observational study in Urinary Calculi and Benign Prostatic Hyperplasia, sponsored by Boston Scientific Corporation. Completed at 4 sites in United States. Per ClinicalTrials.gov, last updated 2025-05-29.
Sponsored by Boston Scientific Corporation · Observational
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.
94 studies on the registry are indexed under Urinary Calculi; 20 are open to participants now.
This study's enrollment of 201 is close to the median of 200 across 31 observational studies indexed under Urinary Calculi.
Browse Urinary Calculi studies →Boston Scientific Corporation is the lead sponsor of 528 studies on the registry; 40 are open to participants now.
Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For Lithotripsy cohort:
For BPH cohort:
Exclusion Criteria:
For Lithotripsy cohort:
For BPH cohort:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects in this cohort will undergo lithotripsy procedure for the treatment of urinary calculi.
Device: Flexiva Pulse High Power Single-Use Laser Fibers
Subjects in this cohort will undergo Holmium Laser Enucleation of the Prostate (HoLEP) procedure for the treatment of BPH.
Device: 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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 month follow-up
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: * Perforation: For Lithotripsy procedures: anywhere in urinary tract. * Hemorrhage resulting in blood loss of ≥ 500mL * Burn
Time frame: Up to 60 days of follow-up for Lithotripsy Cohort
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: * Perforation: For HoLEP procedures: in prostate capsule, bladder, and/or urethra * Hemorrhage resulting in blood loss of ≥ 500mL * Burn
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Through HoLEP procedure completion, up to 1 day.
| Milestone | Lithotripsy Cohort | Benign Prostatic Hyperplasia (BPH) Cohort |
|---|---|---|
| Started | 105 | 104 |
| Completed | 97 | 95 |
| Not completed | 8 | 9 |
| Withdrew: Physician decision | 7 | 3 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Withdrew: Withdrawal by subject | 0 | 2 |
| Withdrew: Non-study fiber used. | 0 | 1 |
| Withdrew: Protocol violation | 0 | 2 |
The primary safety endpoint is the occurrence of Serious Adverse Device Effects (SADE) related to Flexiva Pulse Laser Fibers during lithotripsy procedures.
| Participants | Lithotripsy Cohort |
|---|---|
| Occurrence of Serious Adverse Device Effects - Primary Safety Endpoint | 2 |
The primary safety endpoint is the occurrence of Serious Adverse Device Effects (SADE) related to Flexiva Pulse Laser Fibers during HoLEP procedures.
| Participants | Benign Prostatic Hyperplasia (BPH) Cohort |
|---|---|
| Occurrence of Serious Adverse Device Effects - Primary Safety Endpoint | 3 |
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.
| Participants | Lithotripsy Cohort |
|---|---|
| Stone Free Rates - Primary Efficacy Endpoint 1 | 54 |
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.
| score on a scale | Benign Prostatic Hyperplasia (BPH) Cohort |
|---|---|
| Change in BPH Symptoms - Primary Efficacy Endpoint 2 | -15.8 ± 6.1 |
Procedure related adverse events and/or adverse device effects related to Flexiva Pulse Laser Fibers, including but not limited to: * Perforation: For Lithotripsy procedures: anywhere in urinary tract. * Hemorrhage resulting in blood loss of ≥ 500mL * Burn
| Participants | Lithotripsy Cohort |
|---|---|
| Procedure Related AEs and/or ADEs - Secondary Safety Endpoint | 6 |
Procedure related adverse events and/or adverse device effects related to Flexiva Pulse Laser Fibers, including but not limited to: * Perforation: For HoLEP procedures: in prostate capsule, bladder, and/or urethra * Hemorrhage resulting in blood loss of ≥ 500mL * Burn
| Participants | Benign Prostatic Hyperplasia (BPH) Cohort |
|---|---|
| Procedure Related AEs and/or ADEs - Secondary Safety Endpoint | 31 |
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.
| Participants | Lithotripsy Cohort |
|---|---|
| Ability of Fiber to Deliver Energy - Secondary Efficacy Endpoint 1 | 98 |
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.
| Participants | Benign Prostatic Hyperplasia (BPH) Cohort |
|---|---|
| Ability of Fiber to Deliver Energy - Secondary Efficacy Endpoint 2 | 99 |
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.
| Participants | Lithotripsy Cohort |
|---|---|
| Fiber and Scope Compatibility - Secondary Efficacy Endpoint 1 | 98 |
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.
| Participants | Benign Prostatic Hyperplasia (BPH) Cohort |
|---|---|
| Fiber and Scope Compatibility - Secondary Efficacy Endpoint 2 | 88 |
For HoLEP procedures: • Improvement in uroflowmetry from baseline as measured by change (increase) in maximum urinary flow rate (Qmax) at 3-month follow-up
| mL/s | Benign Prostatic Hyperplasia (BPH) Cohort |
|---|---|
| Change in Uroflowmetry - Secondary Efficacy Endpoint 2 | 15.0 ± 13.9 |
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.
| score on a scale | Benign Prostatic Hyperplasia (BPH) Cohort |
|---|---|
| Change in Quality of Life - Secondary Efficacy Endpoint 2 | -3.4 ± 1.6 |
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.
| Participants | Benign Prostatic Hyperplasia (BPH) Cohort |
|---|---|
| Hemostasis - Secondary Efficacy Endpoint 2 | 99 |
Collected over 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).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lithotripsy Cohort | 0/100 (0%) | 2/100 (2%) | 4/100 (4%) |
| Benign Prostatic Hyperplasia (BPH) Cohort | 0/101 (0%) | 6/101 (5.9%) | 27/101 (26.7%) |
| Event | Lithotripsy Cohort | Benign Prostatic Hyperplasia (BPH) Cohort |
|---|---|---|
| HaematuriaRenal and urinary disorders | 0/100 | 2/101 |
| Urinary RetentionRenal and urinary disorders | 0/100 | 2/101 |
| SepsisInfections and infestations | 1/100 | 0/101 |
| UrosepsisInfections and infestations | 1/100 | 0/101 |
| Bladder StenosisRenal and urinary disorders | 0/100 | 1/101 |
| Prostatic HaemorrhageReproductive system and breast disorders | 0/100 | 1/101 |
| Blood Loss AnaemiaBlood and lymphatic system disorders | 0/100 | 1/101 |
| Event | Lithotripsy Cohort | Benign Prostatic Hyperplasia (BPH) Cohort |
|---|---|---|
| Lower Urinary Tract SymptomsRenal and urinary disorders | 1/100 | 12/101 |
| HaematuriaRenal and urinary disorders | 0/100 | 7/101 |
| Urinary RetentionRenal and urinary disorders | 0/100 | 5/101 |
| CystitisInfections and infestations | 2/100 | 0/101 |
| DysuriaRenal and urinary disorders | 1/100 | 2/101 |
| Urinary IncontinenceRenal and urinary disorders | 0/100 | 2/101 |
| Erectile DysfunctionReproductive system and breast disorders | 0/100 | 2/101 |
| Urinary Tract InfectionInfections and infestations | 0/100 | 2/101 |
| PyelitisInfections and infestations | 1/100 | 0/101 |
| Bladder SpasmRenal and urinary disorders | 0/100 | 1/101 |
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.
| Age, Customized(Participants) | Lithotripsy Cohort | Benign Prostatic Hyperplasia (BPH) Cohort | Total |
|---|---|---|---|
| <18 years | 0 | 0 | 0 |
| 18-64 years | 76 | 37 | 113 |
| ≥65 years | 23 | 64 | 87 |
| Sex: Female, Male(Participants) | Lithotripsy Cohort | Benign Prostatic Hyperplasia (BPH) Cohort | Total |
|---|---|---|---|
| Female | 46 | 0 | 46 |
| Male | 53 | 101 | 154 |
| Ethnicity (NIH/OMB)(Participants) | Lithotripsy Cohort | Benign Prostatic Hyperplasia (BPH) Cohort | Total |
|---|---|---|---|
| Hispanic or Latino | 42 | 24 | 66 |
| Not Hispanic or Latino | 52 | 73 | 125 |
| Unknown or Not Reported | 5 | 4 | 9 |
| Race (NIH/OMB)(Participants) | Lithotripsy Cohort | Benign Prostatic Hyperplasia (BPH) Cohort | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 2 | 3 |
| Native Hawaiian or Other Pacific Islander | 1 | 1 | 2 |
| Black or African American | 2 | 9 | 11 |
| White | 87 | 83 | 170 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 8 | 6 | 14 |
| Region of Enrollment(Participants) | Lithotripsy Cohort | Benign Prostatic Hyperplasia (BPH) Cohort | Total |
|---|---|---|---|
| United States | 99 | 101 | 200 |
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