Urinary CalculiNCT05027971

Flexiva Pulse Registry

An observational study of Urinary Calculi and Benign Prostatic Hyperplasia, run by Boston Scientific Corporation at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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). Read more about this study

Who is it for?: Any age
Conditions the study is for: Urinary Calculi, Benign Prostatic Hyperplasia
What is being tested?: Flexiva Pulse High Power Single-Use Laser Fibers
Type of treatment: Medical device
How many people: 201 participants
Where: 4 sitesUnited States
Study dates: 1 Nov 2021to 31 Oct 2023
How long will I take part?: 6 Months
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: 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.

Who may be able to join

For Lithotripsy cohort:
Subject is undergoing treatment for urinary calculi
Subject is willing and able to return for all follow-up visits
For BPH cohort:
Subject is ≥ 40 years of age
Subject with a diagnosis of benign prostatic hyperplasia (BPH) with lower urinary tract symptoms

Show all 9Show fewer

IPSS (International Prostate Symptom Score) ≥ 12
Qmax (Peak Flow Rate) ≤ 15 mL/s
Subject is willing and able to return for all follow-up visits

Who cannot join

For Lithotripsy cohort:
Subject has uncontrolled bleeding disorders and coagulopathy
Subject has untreated urinary tract infection (UTI)
Subject requires simultaneous HoLEP procedure
For BPH cohort:
Subject has a diagnosis of bladder cancer

Show all 13Show fewer

Subject has a diagnosis of prostate cancer
Subject with prostate-specific antigen (PSA) ˃ 10 ng/mL suggestive of prostate cancer is not eligible unless patient has concomitant negative prostate biopsy
Subject has acute prostatitis, a prostate abscess, or neurogenic bladder
Subject has urethral stricture disorder
Subject has uncontrolled bleeding disorders and coagulopathy
Subject has untreated urinary tract infection (UTI)
Subject requires simultaneous upper urinary calculi lithotripsy procedure (not applicable to bladder calculi)

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
University of Miami
Miami, Florida, 33136
AdventHealth Orlando
Orlando, Florida, 32803
Mayo Clinic Pheonix
Phoenix, Arizona, 85054

Other trials in United States

About this study

Official title: Flexiva Pulse Laser Fiber Post-Market Patient Registry

Read the detailed description

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.

Conditions: Urinary Calculi, Benign Prostatic Hyperplasia
Being tested: Flexiva Pulse High Power Single-Use Laser Fibers
Medical subject headings: Urinary Calculi, Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Flexiva Pulse High Power Single-Use Laser FibersDevice
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.

Study groups in NCT05027971
Study group	Role	What they receive
Lithotripsy Cohort		Subjects in this cohort will undergo lithotripsy procedure for the treatment of urinary calculi. Receives: Device: Flexiva Pulse High Power Single-Use Laser Fibers
Benign Prostatic Hyperplasia (BPH) Cohort		Subjects in this cohort will undergo Holmium Laser Enucleation of the Prostate (HoLEP) procedure for the treatment of BPH. Receives: Device: Flexiva Pulse High Power Single-Use Laser Fibers

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 month follow-up

Secondary outcomes (9)

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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Through HoLEP procedure completion, up to 1 day.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 202131 Oct 2023

First posted31 Aug 2021
Study start1 Nov 2021
Primary completion31 Oct 2023
Study completion31 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Urinary CalculiStudies of the same condition, open and under way.
More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 201 participants (actual)
Target duration: 6 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT05027971
Sponsor's protocol ID: 92704912
Status last verified: May 2025
First submitted: 6 Aug 2021
Last updated: 29 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Flexiva Pulse Laser Fiber Post-Market Patient Registry
ClinicalTrials.gov ID: NCT05027971
Acronym / sponsor ID: 92704912
Conditions: Urinary Calculi, Benign Prostatic Hyperplasia
Study type: Observational
Recruitment status: Completed
Enrolment: 201 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: 1 Nov 2021 (actual)
Primary completion: 31 Oct 2023 (actual)
Study completion: 31 Oct 2023 (actual)
First posted: 31 Aug 2021 (actual)
Results: Posted 26 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Multi-center, open label, prospective study to document on-going post-market safety and performance of Flexiva Pulse High Power Single-Use Laser Fibers.

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 6 Months
Number of arms: 2

Arm	Type	Receives
Lithotripsy Cohort	–	Device: Flexiva Pulse High Power Single-Use Laser FibersSubjects in this cohort will undergo lithotripsy procedure for the treatment of urinary calculi.
Benign Prostatic Hyperplasia (BPH) Cohort	–	Device: Flexiva Pulse High Power Single-Use Laser FibersSubjects in this cohort will undergo Holmium Laser Enucleation of the Prostate (HoLEP) procedure for the treatment of BPH.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: 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.

Key inclusion criteria (9 listed)

Subject is undergoing treatment for urinary calculi
Subject is willing and able to return for all follow-up visits
Subject is ≥ 40 years of age
Subject with a diagnosis of benign prostatic hyperplasia (BPH) with lower urinary tract symptoms
IPSS (International Prostate Symptom Score) ≥ 12

Key exclusion criteria (13 listed)

Subject has uncontrolled bleeding disorders and coagulopathy
Subject has untreated urinary tract infection (UTI)
Subject requires simultaneous HoLEP procedure
Subject has a diagnosis of bladder cancer
Subject has a diagnosis of prostate cancer

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Flexiva Pulse High Power Single-Use Laser FibersFlexiva 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.	Device	Benign Prostatic Hyperplasia (BPH) Cohort, Lithotripsy Cohort

Primary outcome

Occurrence of Serious Adverse Device Effects - Primary Safety Endpoint
Time frame: Up to 60 days of follow-up for Lithotripsy Cohort
The primary safety endpoint is the occurrence of Serious Adverse Device Effects (SADE) related to Flexiva Pulse Laser Fibers during lithotripsy procedures.
Occurrence of Serious Adverse Device Effects - Primary Safety Endpoint
Time frame: Up to 240 days of follow-up for BPH Cohort.
The primary safety endpoint is the occurrence of Serious Adverse Device Effects (SADE) related to Flexiva Pulse Laser Fibers during HoLEP procedures.
Stone Free Rates - Primary Efficacy Endpoint 1
Time frame: 1 month follow-up
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.
Change in BPH Symptoms - Primary Efficacy Endpoint 2
Time frame: 3 month follow-up
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.

9 secondary outcomes

Procedure Related AEs and/or ADEs - Secondary Safety Endpoint
Time frame: Up to 60 days of follow-up for Lithotripsy Cohort
Procedure Related AEs and/or ADEs - Secondary Safety Endpoint
Time frame: Up to 240 days of follow-up for BPH Cohort.
Ability of Fiber to Deliver Energy - Secondary Efficacy Endpoint 1
Time frame: Through lithotripsy procedure completion, up to 1 day.
Ability of Fiber to Deliver Energy - Secondary Efficacy Endpoint 2
Time frame: Through HoLEP procedure completion, up to 1 day.
Fiber and Scope Compatibility - Secondary Efficacy Endpoint 1
Time frame: Through lithotripsy procedure completion, up to 1 day.
Fiber and Scope Compatibility - Secondary Efficacy Endpoint 2
Time frame: Through HoLEP procedure completion, up to 1 day.
Change in Uroflowmetry - Secondary Efficacy Endpoint 2
Time frame: Up to 3 month follow-up
Change in Quality of Life - Secondary Efficacy Endpoint 2
Time frame: Up to 3 month follow-up
Hemostasis - Secondary Efficacy Endpoint 2
Time frame: Through HoLEP procedure completion, up to 1 day.

Results and safety

Results posted to the registry on 26 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lithotripsy Cohort	105	97
Benign Prostatic Hyperplasia (BPH) Cohort	104	95

Primary outcome: Occurrence of Serious Adverse Device Effects - Primary Safety Endpoint

Time frame: Up to 60 days of follow-up for Lithotripsy Cohort. Count of participants. Unit: Participants

Measure	Lithotripsy Cohort n = 100
Value	2

Lithotripsy Cohort: Proportion by cohort: .02 (95% CI .002 to .07)

Population analysed: 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.

Primary outcome: Occurrence of Serious Adverse Device Effects - Primary Safety Endpoint

Time frame: Up to 240 days of follow-up for BPH Cohort.. Count of participants. Unit: Participants

Measure	Benign Prostatic Hyperplasia (BPH) Cohort n = 101
Value	3

Benign Prostatic Hyperplasia (BPH) Cohort: Proportion by cohort: .03 (95% CI .006 to .084)

Primary outcome: Stone Free Rates - Primary Efficacy Endpoint 1

Time frame: 1 month follow-up. Count of participants. Unit: Participants

Measure	Lithotripsy Cohort n = 81
Value	54

Lithotripsy Cohort: Proportion by cohort: .667 (95% CI .553 to .768)

Population analysed: 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.

Primary outcome: Change in BPH Symptoms - Primary Efficacy Endpoint 2

Time frame: 3 month follow-up. Mean (Standard Deviation). Unit: score on a scale

Measure	Benign Prostatic Hyperplasia (BPH) Cohort n = 57
Value	-15.8 (6.1)

Benign Prostatic Hyperplasia (BPH) Cohort: Mean Difference (Final Values): -15.8 (95% CI -17.4 to -14.2)

Population analysed: 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.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lithotripsy Cohort	2 of 100 (2%)	4 of 100 (4%)	0 of 100
Benign Prostatic Hyperplasia (BPH) Cohort	6 of 101 (5.9%)	27 of 101 (26.7%)	0 of 101

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Urinary Calculi and Benign Prostatic Hyperplasia, run by Boston Scientific Corporation at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of Serious Adverse Device Effects - Primary Safety Endpoint (time frame: Up to 60 days of follow-up for Lithotripsy Cohort). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05027971.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.