Trial Outcomes & Findings for Study of an Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stone Disease (NCT NCT04771182)
NCT ID: NCT04771182
Last Updated: 2026-04-03
Results Overview
Proportion of study participants who, after up to 2 ELS treatments, have a complete absence of stones or with any residual fragments measuring less than 3 mm in the largest dimension as assessed by follow-up imaging
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
30 days
Results posted on
2026-04-03
Participant Flow
Participant milestones
| Measure |
Enhanced Lithotripsy System
Treatment of urinary stone disease with the Enhanced Lithotripsy System
Enhanced Lithotripsy System: Treatment of urinary stone disease with the Enhanced Lithotripsy System
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Enhanced Lithotripsy System
n=25 Participants
Treatment of urinary stone disease with the Enhanced Lithotripsy System
Enhanced Lithotripsy System: Treatment of urinary stone disease with the Enhanced Lithotripsy System
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=25 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=25 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=25 Participants
|
|
Age, Continuous
|
50.3 years
n=25 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=25 Participants
|
|
Region of Enrollment
Australia
|
25 participants
n=25 Participants
|
|
BMI
|
28.79 kg/m^2
n=25 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: Proportion of study participants who, after up to 2 ELS treatments, have a complete absence of stones or with any residual fragments measuring less than 3 mm in the largest dimension as assessed by follow-up imaging
Proportion of study participants who, after up to 2 ELS treatments, have a complete absence of stones or with any residual fragments measuring less than 3 mm in the largest dimension as assessed by follow-up imaging
Outcome measures
| Measure |
Enhanced Lithotripsy System
n=25 Participants
Treatment of urinary stone disease with the Enhanced Lithotripsy System
|
|---|---|
|
Number of Participants With Treatment Success
|
17 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Subjects reporting Serious Device and/or Serious Procedure-Related adverse events
Incidence of Serious Device and/or Serious Procedure-Related adverse events
Outcome measures
| Measure |
Enhanced Lithotripsy System
n=25 Participants
Treatment of urinary stone disease with the Enhanced Lithotripsy System
|
|---|---|
|
Percentage of Participants With Serious Device and/or Serious Procedure-Related Adverse Events (Safety)
|
4 Participants
|
Adverse Events
Enhanced Lithotripsy System
Serious events: 4 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Enhanced Lithotripsy System
n=25 participants at risk
Treatment of urinary stone disease with the Enhanced Lithotripsy System
Enhanced Lithotripsy System: Treatment of urinary stone disease with the Enhanced Lithotripsy System
|
|---|---|
|
Cardiac disorders
Paroxysmal Atrial Fibrillation
|
4.0%
1/25 • Number of events 1 • 30 days
|
|
Renal and urinary disorders
Haematuria
|
4.0%
1/25 • Number of events 1 • 30 days
|
|
Cardiac disorders
Myocardia Infarction
|
4.0%
1/25 • Number of events 1 • 30 days
|
|
General disorders
Pain: Flank Pain
|
12.0%
3/25 • Number of events 3 • 30 days
|
|
Musculoskeletal and connective tissue disorders
Other: Fracture
|
4.0%
1/25 • Number of events 1 • 30 days
|
Other adverse events
| Measure |
Enhanced Lithotripsy System
n=25 participants at risk
Treatment of urinary stone disease with the Enhanced Lithotripsy System
Enhanced Lithotripsy System: Treatment of urinary stone disease with the Enhanced Lithotripsy System
|
|---|---|
|
Cardiac disorders
Hypotension
|
4.0%
1/25 • Number of events 1 • 30 days
|
|
Gastrointestinal disorders
Altered bowel problems
|
4.0%
1/25 • Number of events 1 • 30 days
|
|
General disorders
Pain: Flank Pain
|
8.0%
2/25 • Number of events 2 • 30 days
|
|
General disorders
Pain, Other: Hip Pain
|
4.0%
1/25 • Number of events 1 • 30 days
|
|
General disorders
Pain, Other: Left Groin Pain
|
4.0%
1/25 • Number of events 1 • 30 days
|
|
Renal and urinary disorders
Glucose in Urine
|
4.0%
1/25 • Number of events 1 • 30 days
|
|
Renal and urinary disorders
Haematuria
|
4.0%
1/25 • Number of events 2 • 30 days
|
|
Renal and urinary disorders
Increased Urinary Frequency
|
4.0%
1/25 • Number of events 1 • 30 days
|
|
Renal and urinary disorders
Intermittent Urinary Frequency
|
8.0%
2/25 • Number of events 2 • 30 days
|
|
Renal and urinary disorders
Retained Calculi
|
4.0%
1/25 • Number of events 1 • 30 days
|
|
Cardiac disorders
Atrial Fibrillation
|
4.0%
1/25 • Number of events 1 • 30 days
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
4.0%
1/25 • Number of events 1 • 30 days
|
|
Renal and urinary disorders
Urinary Tract / bladder or other infection in the genitourinary system
|
8.0%
2/25 • Number of events 2 • 30 days
|
|
General disorders
Pain: Dysuria
|
4.0%
1/25 • Number of events 1 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
4.0%
1/25 • Number of events 1 • 30 days
|
|
Renal and urinary disorders
Altered Creatinine Levels
|
4.0%
1/25 • Number of events 1 • 30 days
|
|
Renal and urinary disorders
Urethral Stricture
|
4.0%
1/25 • Number of events 1 • 30 days
|
|
General disorders
Elevated Temperature
|
4.0%
1/25 • Number of events 1 • 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place