Trial Outcomes & Findings for Flexiva Pulse Registry (NCT NCT05027971)
NCT ID: NCT05027971
Last Updated: 2025-05-29
Results Overview
The primary safety endpoint is the occurrence of Serious Adverse Device Effects (SADE) related to Flexiva Pulse Laser Fibers during lithotripsy procedures.
Recruitment status
COMPLETED
Target enrollment
201 participants
Primary outcome timeframe
Up to 60 days of follow-up for Lithotripsy Cohort
Results posted on
2025-05-29
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
105
|
104
|
|
Overall Study
COMPLETED
|
97
|
95
|
|
Overall Study
NOT COMPLETED
|
8
|
9
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Physician Decision
|
7
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Non-study fiber used.
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
2
|
Baseline Characteristics
Flexiva Pulse Registry
Baseline characteristics by cohort
| Measure |
Lithotripsy Cohort
n=99 Participants
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.
|
Benign Prostatic Hyperplasia (BPH) Cohort
n=101 Participants
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.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
18-64 years
|
76 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Age, Customized
≥65 years
|
23 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
42 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
87 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
99 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 60 days of follow-up for Lithotripsy CohortPopulation: 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.
The primary safety endpoint is the occurrence of Serious Adverse Device Effects (SADE) related to Flexiva Pulse Laser Fibers during lithotripsy procedures.
Outcome measures
| Measure |
Lithotripsy Cohort
n=100 Participants
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.
|
|---|---|
|
Occurrence of Serious Adverse Device Effects - Primary Safety Endpoint
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to 240 days of follow-up for BPH Cohort.Population: 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.
The primary safety endpoint is the occurrence of Serious Adverse Device Effects (SADE) related to Flexiva Pulse Laser Fibers during HoLEP procedures.
Outcome measures
| Measure |
Lithotripsy Cohort
n=101 Participants
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.
|
|---|---|
|
Occurrence of Serious Adverse Device Effects - Primary Safety Endpoint
|
3 Participants
|
PRIMARY outcome
Timeframe: 1 month follow-upPopulation: 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.
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.
Outcome measures
| Measure |
Lithotripsy Cohort
n=81 Participants
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.
|
|---|---|
|
Stone Free Rates - Primary Efficacy Endpoint 1
|
54 Participants
|
PRIMARY outcome
Timeframe: 3 month follow-upPopulation: 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.
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.
Outcome measures
| Measure |
Lithotripsy Cohort
n=57 Participants
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.
|
|---|---|
|
Change in BPH Symptoms - Primary Efficacy Endpoint 2
|
-15.8 score on a scale
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: Up to 60 days of follow-up for Lithotripsy CohortPopulation: 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.
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
Outcome measures
| Measure |
Lithotripsy Cohort
n=100 Participants
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.
|
|---|---|
|
Procedure Related AEs and/or ADEs - Secondary Safety Endpoint
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 240 days of follow-up for BPH Cohort.Population: 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.
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
Outcome measures
| Measure |
Lithotripsy Cohort
n=101 Participants
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.
|
|---|---|
|
Procedure Related AEs and/or ADEs - Secondary Safety Endpoint
|
31 Participants
|
SECONDARY outcome
Timeframe: Through lithotripsy procedure completion, up to 1 day.Population: Statistics are based on the number of Flexiva Pulse fibers used in all subjects for which data was available.
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.
Outcome measures
| Measure |
Lithotripsy Cohort
n=98 Participants
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.
|
|---|---|
|
Ability of Fiber to Deliver Energy - Secondary Efficacy Endpoint 1
|
98 Participants
|
SECONDARY outcome
Timeframe: Through HoLEP procedure completion, up to 1 day.Population: Statistics are based on the number of Flexiva Pulse fibers used in all subjects for which data was available.
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.
Outcome measures
| Measure |
Lithotripsy Cohort
n=99 Participants
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.
|
|---|---|
|
Ability of Fiber to Deliver Energy - Secondary Efficacy Endpoint 2
|
99 Participants
|
SECONDARY outcome
Timeframe: Through lithotripsy procedure completion, up to 1 day.Population: Statistics are based on the number of Flexiva Pulse fibers used in all subjects for which data was available.
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.
Outcome measures
| Measure |
Lithotripsy Cohort
n=98 Participants
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.
|
|---|---|
|
Fiber and Scope Compatibility - Secondary Efficacy Endpoint 1
|
98 Participants
|
SECONDARY outcome
Timeframe: Through HoLEP procedure completion, up to 1 day.Population: Statistics are based on the number of Flexiva Pulse fibers used in all subjects for which data was available.
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.
Outcome measures
| Measure |
Lithotripsy Cohort
n=99 Participants
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.
|
|---|---|
|
Fiber and Scope Compatibility - Secondary Efficacy Endpoint 2
|
88 Participants
|
SECONDARY outcome
Timeframe: Up to 3 month follow-upPopulation: 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.
For HoLEP procedures: • Improvement in uroflowmetry from baseline as measured by change (increase) in maximum urinary flow rate (Qmax) at 3-month follow-up
Outcome measures
| Measure |
Lithotripsy Cohort
n=58 Participants
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.
|
|---|---|
|
Change in Uroflowmetry - Secondary Efficacy Endpoint 2
|
15.0 mL/s
Standard Deviation 13.9
|
SECONDARY outcome
Timeframe: Up to 3 month follow-upPopulation: 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.
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.
Outcome measures
| Measure |
Lithotripsy Cohort
n=41 Participants
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.
|
|---|---|
|
Change in Quality of Life - Secondary Efficacy Endpoint 2
|
-3.4 score on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Through HoLEP procedure completion, up to 1 day.Population: 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.
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.
Outcome measures
| Measure |
Lithotripsy Cohort
n=99 Participants
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.
|
|---|---|
|
Hemostasis - Secondary Efficacy Endpoint 2
|
99 Participants
|
Adverse Events
Lithotripsy Cohort
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Benign Prostatic Hyperplasia (BPH) Cohort
Serious events: 6 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lithotripsy Cohort
n=100 participants at risk
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.
|
Benign Prostatic Hyperplasia (BPH) Cohort
n=101 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Sepsis
|
1.0%
1/100 • Number of events 1 • 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
|
0.00%
0/101 • 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
|
|
Infections and infestations
Urosepsis
|
1.0%
1/100 • Number of events 1 • 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
|
0.00%
0/101 • 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
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/100 • 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
|
2.0%
2/101 • Number of events 2 • 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
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/100 • 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
|
2.0%
2/101 • Number of events 3 • 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
|
|
Renal and urinary disorders
Bladder Stenosis
|
0.00%
0/100 • 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
|
0.99%
1/101 • Number of events 1 • 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
|
|
Reproductive system and breast disorders
Prostatic Haemorrhage
|
0.00%
0/100 • 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
|
0.99%
1/101 • Number of events 1 • 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
|
|
Blood and lymphatic system disorders
Blood Loss Anaemia
|
0.00%
0/100 • 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
|
0.99%
1/101 • Number of events 1 • 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
|
Other adverse events
| Measure |
Lithotripsy Cohort
n=100 participants at risk
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.
|
Benign Prostatic Hyperplasia (BPH) Cohort
n=101 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Cystitis
|
2.0%
2/100 • Number of events 2 • 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
|
0.00%
0/101 • 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
|
|
Infections and infestations
Pyelitis
|
1.0%
1/100 • Number of events 1 • 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
|
0.00%
0/101 • 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
|
|
Renal and urinary disorders
Dysuria
|
1.0%
1/100 • Number of events 1 • 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
|
2.0%
2/101 • Number of events 2 • 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
|
|
Renal and urinary disorders
Lower Urinary Tract Symptoms
|
1.0%
1/100 • Number of events 1 • 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
|
11.9%
12/101 • Number of events 12 • 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
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/100 • 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
|
6.9%
7/101 • Number of events 7 • 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
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/100 • 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
|
5.0%
5/101 • Number of events 5 • 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
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/100 • 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
|
2.0%
2/101 • Number of events 2 • 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
|
|
Renal and urinary disorders
Bladder Spasm
|
0.00%
0/100 • 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
|
0.99%
1/101 • Number of events 1 • 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
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/100 • 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
|
0.99%
1/101 • Number of events 1 • 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
|
|
Renal and urinary disorders
Stress Urinary Incontinence
|
0.00%
0/100 • 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
|
0.99%
1/101 • Number of events 1 • 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
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
0.00%
0/100 • 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
|
2.0%
2/101 • Number of events 2 • 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
|
|
Reproductive system and breast disorders
Pelvic Discomfort
|
0.00%
0/100 • 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
|
0.99%
1/101 • Number of events 1 • 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
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/100 • 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
|
2.0%
2/101 • Number of events 2 • 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
|
|
Product Issues
Device Occlusion
|
0.00%
0/100 • 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
|
0.99%
1/101 • Number of events 1 • 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
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60