Trial Outcomes & Findings for Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II (NCT NCT03123250)
NCT ID: NCT03123250
Last Updated: 2023-06-28
Results Overview
The percentage of subjects with adverse events rated as probably or definitely related to the study procedure classified as Clavien-Dindo Grade 2 or higher or any Grade 1 event resulting in persistent disability (e.g. ejaculatory disorder or erectile dysfunction) evidenced through 3 months post treatment.
COMPLETED
NA
101 participants
3 months post-treatment
2023-06-28
Participant Flow
Participant milestones
| Measure |
Aquablation Procedure
Aquablation: To utilizes proprietary heat-free high-velocity waterjet technology to resect and remove prostate tissue using the AQUABEAM system, which is a personalized image-guided tissue removal system.
|
|---|---|
|
Treatment
STARTED
|
101
|
|
Treatment
COMPLETED
|
101
|
|
Treatment
NOT COMPLETED
|
0
|
|
1 Month Follow-Up
STARTED
|
101
|
|
1 Month Follow-Up
COMPLETED
|
101
|
|
1 Month Follow-Up
NOT COMPLETED
|
0
|
|
3 Months Follow-Up
STARTED
|
99
|
|
3 Months Follow-Up
COMPLETED
|
99
|
|
3 Months Follow-Up
NOT COMPLETED
|
0
|
|
6 Months Follow-Up
STARTED
|
100
|
|
6 Months Follow-Up
COMPLETED
|
100
|
|
6 Months Follow-Up
NOT COMPLETED
|
0
|
|
12 Months Follow-Up
STARTED
|
96
|
|
12 Months Follow-Up
COMPLETED
|
96
|
|
12 Months Follow-Up
NOT COMPLETED
|
0
|
|
24 Months Follow-Up
STARTED
|
86
|
|
24 Months Follow-Up
COMPLETED
|
86
|
|
24 Months Follow-Up
NOT COMPLETED
|
0
|
|
36 Months Follow-Up
STARTED
|
82
|
|
36 Months Follow-Up
COMPLETED
|
82
|
|
36 Months Follow-Up
NOT COMPLETED
|
0
|
|
48 Months Follow-Up
STARTED
|
66
|
|
48 Months Follow-Up
COMPLETED
|
66
|
|
48 Months Follow-Up
NOT COMPLETED
|
0
|
|
60 Months Follow Up
STARTED
|
62
|
|
60 Months Follow Up
COMPLETED
|
60
|
|
60 Months Follow Up
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Aquablation Procedure
Aquablation: To utilizes proprietary heat-free high-velocity waterjet technology to resect and remove prostate tissue using the AQUABEAM system, which is a personalized image-guided tissue removal system.
|
|---|---|
|
60 Months Follow Up
Withdrawal by Subject
|
2
|
Baseline Characteristics
Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II
Baseline characteristics by cohort
| Measure |
Aquablation Procedure
n=101 Participants
Aquablation: To utilizes proprietary heat-free high-velocity waterjet technology to resect and remove prostate tissue using the AQUABEAM system, which is a personalized image-guided tissue removal system.
|
|---|---|
|
Age, Continuous
|
67.5 years
STANDARD_DEVIATION 6.6 • n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
101 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
92 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
5 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
6 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
88 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
2 Participants
n=93 Participants
|
|
Region of Enrollment
Canada
|
19 participants
n=93 Participants
|
|
Region of Enrollment
United States
|
82 participants
n=93 Participants
|
|
Body mass index
|
28.4 kg/m^2
STANDARD_DEVIATION 4.2 • n=93 Participants
|
|
Prostate size (TRUS)
|
107.4 cc
STANDARD_DEVIATION 22.1 • n=93 Participants
|
|
International Prostate Symptom Score (IPSS)
|
23.2 score on a scale
STANDARD_DEVIATION 6.3 • n=93 Participants
|
PRIMARY outcome
Timeframe: 3 months post-treatmentThe percentage of subjects with adverse events rated as probably or definitely related to the study procedure classified as Clavien-Dindo Grade 2 or higher or any Grade 1 event resulting in persistent disability (e.g. ejaculatory disorder or erectile dysfunction) evidenced through 3 months post treatment.
Outcome measures
| Measure |
Aquablation Procedure
n=101 Participants
Aquablation: To utilizes proprietary heat-free high-velocity waterjet technology to resect and remove prostate tissue using the AQUABEAM system, which is a personalized image-guided tissue removal system.
|
|---|---|
|
Incidence of Clavien-Dindo Adverse Events (Percentage of Participants) Through 3 Months Post Treatment
|
45.5 percentage
|
PRIMARY outcome
Timeframe: 3 months post-treatmentPopulation: The number of participants analyzed for this outcome measure consist of the participants who completed the IPSS questionnaire at 3 months post-treatment.
The change in total IPSS score at 3 months as compared to baseline. The objective of the International Prostate Symptom Score (IPSS) is to capture the severity of urinary symptoms related to benign prostatic hyperplasia IPSS ranges from 0 to 35. A higher score indicates a worse outcome.
Outcome measures
| Measure |
Aquablation Procedure
n=95 Participants
Aquablation: To utilizes proprietary heat-free high-velocity waterjet technology to resect and remove prostate tissue using the AQUABEAM system, which is a personalized image-guided tissue removal system.
|
|---|---|
|
Change in Total International Prostate Symptom Score (IPSS) Score at 3 Months as Compared to Baseline
|
-16.5 score on a scale
Interval -18.1 to -14.8
|
POST_HOC outcome
Timeframe: 60 months post-treatmentThe change in total IPSS score at 60 months as compared to baseline The objective of the International Prostate Symptom Score (IPSS) is to capture the severity of urinary symptoms related to benign prostatic hyperplasia IPSS ranges from 0 to 35. A higher score indicates a worse outcome.
Outcome measures
Outcome data not reported
Adverse Events
Aquablation Procedure
Serious adverse events
| Measure |
Aquablation Procedure
n=101 participants at risk
Aquablation: To utilizes proprietary heat-free high-velocity waterjet technology to resect and remove prostate tissue using the AQUABEAM system, which is a personalized image-guided tissue removal system.
|
|---|---|
|
Surgical and medical procedures
Bleeding
|
8.9%
9/101 • Number of events 9 • 2 years
|
|
Cardiac disorders
Cardiac
|
3.0%
3/101 • Number of events 3 • 2 years
|
|
Nervous system disorders
Cerebrovascular accident
|
0.99%
1/101 • Number of events 1 • 2 years
|
|
General disorders
Multi-system organ failure
|
0.99%
1/101 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Urinary incontinence
|
0.99%
1/101 • Number of events 1 • 2 years
|
|
General disorders
Other
|
3.0%
3/101 • Number of events 3 • 2 years
|
|
Reproductive system and breast disorders
Scrotal edema
|
2.0%
2/101 • Number of events 3 • 2 years
|
|
Renal and urinary disorders
Urinary retention
|
0.99%
1/101 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
Aquablation Procedure
n=101 participants at risk
Aquablation: To utilizes proprietary heat-free high-velocity waterjet technology to resect and remove prostate tissue using the AQUABEAM system, which is a personalized image-guided tissue removal system.
|
|---|---|
|
Surgical and medical procedures
Bleeding
|
7.9%
8/101 • 2 years
|
|
Renal and urinary disorders
Dysuria
|
11.9%
12/101 • 2 years
|
|
Reproductive system and breast disorders
Ejaculatory dysfunction
|
22.8%
23/101 • 2 years
|
|
General disorders
Pain
|
5.9%
6/101 • 2 years
|
|
Renal and urinary disorders
Urinary incontinence
|
15.8%
16/101 • 2 years
|
|
Infections and infestations
Urinary tract infection
|
11.9%
12/101 • 2 years
|
|
General disorders
Other
|
13.9%
14/101 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60