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Trial Outcomes & Findings for Acoustic Enhancer Research on Laser Lithotripsy (AEROLITH) (NCT NCT04563039)

NCT ID: NCT04563039

Last Updated: 2025-04-24

Results Overview

Study subjects who present with a complete absence of stones, or have residual fragments measuring less than or equal to 2 mm on the treatment side, as assessed by CT imaging

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

196 participants

Primary outcome timeframe

At 30 days post index procedure

Results posted on

2025-04-24

Participant Flow

Participant milestones

Participant milestones
Measure
Ureteroscopic Laser Lithotripsy With Acoustic Enhancer
Ureteroscopic Laser Lithotripsy with Acoustic Enhancer Ureteroscopy Laser Lithotripsy (URS-LL) with Acoustic Enhancer: Applaud's Acoustic Enhancer is provided in a lyophilized form. After reconstitution, it is a liquid, containing micron-scale particles that are made of a perfluoroalkane gas core with a lipid shell. The device is intended to be used with cleared/approved pulsed laser systems in fragmenting urinary stones (calculi) in the upper (superior) pole, lower (inferior) pole, and interpolar region of the kidney, pelvis of the kidney, and proximal ureter.
Standard Ureteroscopic Laser Lithotripsy
Standard Ureteroscopic Laser Lithotripsy Standard Ureteroscopic Laser Lithotripsy: Standard of care Ureteroscopic Laser Lithotripsy
Overall Study
STARTED
103
93
Overall Study
COMPLETED
100
90
Overall Study
NOT COMPLETED
3
3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Acoustic Enhancer Research on Laser Lithotripsy (AEROLITH)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Ureteroscopic Laser Lithotripsy With Acoustic Enhancer
n=103 Participants
Ureteroscopic Laser Lithotripsy with Acoustic Enhancer Ureteroscopy Laser Lithotripsy (URS-LL) with Acoustic Enhancer: Applaud's Acoustic Enhancer is provided in a lyophilized form. After reconstitution, it is a liquid, containing micron-scale particles that are made of a perfluoroalkane gas core with a lipid shell. The device is intended to be used with cleared/approved pulsed laser systems in fragmenting urinary stones (calculi) in the upper (superior) pole, lower (inferior) pole, and interpolar region of the kidney, pelvis of the kidney, and proximal ureter.
Standard Ureteroscopic Laser Lithotripsy
n=93 Participants
Standard Ureteroscopic Laser Lithotripsy Standard Ureteroscopic Laser Lithotripsy: Standard of care Ureteroscopic Laser Lithotripsy
Total
n=196 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=39 Participants
0 Participants
n=41 Participants
0 Participants
n=35 Participants
Age, Categorical
Between 18 and 65 years
103 Participants
n=39 Participants
93 Participants
n=41 Participants
196 Participants
n=35 Participants
Age, Categorical
>=65 years
0 Participants
n=39 Participants
0 Participants
n=41 Participants
0 Participants
n=35 Participants
Age, Continuous
50.8 years
n=39 Participants
54.7 years
n=41 Participants
52.7 years
n=35 Participants
Sex: Female, Male
Female
52 Participants
n=39 Participants
46 Participants
n=41 Participants
98 Participants
n=35 Participants
Sex: Female, Male
Male
51 Participants
n=39 Participants
47 Participants
n=41 Participants
98 Participants
n=35 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
18 Participants
n=39 Participants
14 Participants
n=41 Participants
32 Participants
n=35 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
85 Participants
n=39 Participants
79 Participants
n=41 Participants
164 Participants
n=35 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=39 Participants
0 Participants
n=41 Participants
0 Participants
n=35 Participants
Region of Enrollment
United States
103 participants
n=39 Participants
93 participants
n=41 Participants
196 participants
n=35 Participants
BMI
31.183 kg/m^2
n=39 Participants
30.785 kg/m^2
n=41 Participants
30.994 kg/m^2
n=35 Participants

PRIMARY outcome

Timeframe: At 30 days post index procedure

Study subjects who present with a complete absence of stones, or have residual fragments measuring less than or equal to 2 mm on the treatment side, as assessed by CT imaging

Outcome measures

Outcome measures
Measure
Ureteroscopic Laser Lithotripsy With Acoustic Enhancer
n=100 Participants
Ureteroscopic Laser Lithotripsy with Acoustic Enhancer Ureteroscopy Laser Lithotripsy (URS-LL) with Acoustic Enhancer: Applaud's Acoustic Enhancer is provided in a lyophilized form. After reconstitution, it is a liquid, containing micron-scale particles that are made of a perfluoroalkane gas core with a lipid shell. The device is intended to be used with cleared/approved pulsed laser systems in fragmenting urinary stones (calculi) in the upper (superior) pole, lower (inferior) pole, and interpolar region of the kidney, pelvis of the kidney, and proximal ureter.
Standard Ureteroscopic Laser Lithotripsy
n=90 Participants
Standard Ureteroscopic Laser Lithotripsy Standard Ureteroscopic Laser Lithotripsy: Standard of care Ureteroscopic Laser Lithotripsy
Number of Participants With Absence of or Have Residual Fragments Measuring Less </= to 2 mm
41 participants
42 participants

Adverse Events

Ureteroscopic Laser Lithotripsy With Acoustic Enhancer

Serious events: 4 serious events
Other events: 36 other events
Deaths: 0 deaths

Standard Ureteroscopic Laser Lithotripsy

Serious events: 5 serious events
Other events: 43 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Ureteroscopic Laser Lithotripsy With Acoustic Enhancer
n=103 participants at risk
Ureteroscopic Laser Lithotripsy with Acoustic Enhancer Ureteroscopy Laser Lithotripsy (URS-LL) with Acoustic Enhancer: Applaud's Acoustic Enhancer is provided in a lyophilized form. After reconstitution, it is a liquid, containing micron-scale particles that are made of a perfluoroalkane gas core with a lipid shell. The device is intended to be used with cleared/approved pulsed laser systems in fragmenting urinary stones (calculi) in the upper (superior) pole, lower (inferior) pole, and interpolar region of the kidney, pelvis of the kidney, and proximal ureter.
Standard Ureteroscopic Laser Lithotripsy
n=93 participants at risk
Standard Ureteroscopic Laser Lithotripsy Standard Ureteroscopic Laser Lithotripsy: Standard of care Ureteroscopic Laser Lithotripsy
Respiratory, thoracic and mediastinal disorders
Pulmonary / respiratory
0.00%
0/103 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
1.1%
1/93 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
Renal and urinary disorders
Infection: Urinary Tract
3.9%
4/103 • Number of events 6 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
2.2%
2/93 • Number of events 5 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
Psychiatric disorders
Psychological
0.00%
0/103 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
1.1%
1/93 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
Renal and urinary disorders
Pain
0.00%
0/103 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
1.1%
1/93 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
Reproductive system and breast disorders
Infection: Genital urinary
0.97%
1/103 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
0.00%
0/93 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
Renal and urinary disorders
Steinstrasse
0.97%
1/103 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
0.00%
0/93 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).

Other adverse events

Other adverse events
Measure
Ureteroscopic Laser Lithotripsy With Acoustic Enhancer
n=103 participants at risk
Ureteroscopic Laser Lithotripsy with Acoustic Enhancer Ureteroscopy Laser Lithotripsy (URS-LL) with Acoustic Enhancer: Applaud's Acoustic Enhancer is provided in a lyophilized form. After reconstitution, it is a liquid, containing micron-scale particles that are made of a perfluoroalkane gas core with a lipid shell. The device is intended to be used with cleared/approved pulsed laser systems in fragmenting urinary stones (calculi) in the upper (superior) pole, lower (inferior) pole, and interpolar region of the kidney, pelvis of the kidney, and proximal ureter.
Standard Ureteroscopic Laser Lithotripsy
n=93 participants at risk
Standard Ureteroscopic Laser Lithotripsy Standard Ureteroscopic Laser Lithotripsy: Standard of care Ureteroscopic Laser Lithotripsy
Vascular disorders
Bleeding / vascular disorders
0.00%
0/103 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
1.1%
1/93 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
Cardiac disorders
Cardiovascular: Other
0.00%
0/103 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
1.1%
1/93 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
Skin and subcutaneous tissue disorders
Burns
0.00%
0/103 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
1.1%
1/93 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
Gastrointestinal disorders
Altered bowel patters
0.00%
0/103 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
2.2%
2/93 • Number of events 3 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
Gastrointestinal disorders
Nausea
2.9%
3/103 • Number of events 3 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
4.3%
4/93 • Number of events 4 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
Gastrointestinal disorders
Nausea and vomiting
0.97%
1/103 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
3.2%
3/93 • Number of events 3 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
Gastrointestinal disorders
Constipation
0.97%
1/103 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
0.00%
0/93 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
Gastrointestinal disorders
Worsening irritable bowel syndrome
0.00%
0/103 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
1.1%
1/93 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
Infections and infestations
Infection: Fever
0.00%
0/103 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
1.1%
1/93 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
Infections and infestations
Vaginal Yeast Infection
0.00%
0/103 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
2.2%
2/93 • Number of events 2 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
Infections and infestations
Pyelonephritis
0.00%
0/103 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
1.1%
1/93 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
Infections and infestations
Infection in the genitourinary system
3.9%
4/103 • Number of events 4 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
3.2%
3/93 • Number of events 5 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
Injury, poisoning and procedural complications
Damage to ureter
0.97%
1/103 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
2.2%
2/93 • Number of events 2 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
Injury, poisoning and procedural complications
Ureteral mucosal injury
0.97%
1/103 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
0.00%
0/93 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
Respiratory, thoracic and mediastinal disorders
COVID-19 related
0.00%
0/103 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
3.2%
3/93 • Number of events 3 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
Renal and urinary disorders
Burning
0.97%
1/103 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
0.00%
0/93 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
General disorders
Back pain
0.00%
0/103 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
1.1%
1/93 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
General disorders
Chest pain
0.97%
1/103 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
0.00%
0/93 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
General disorders
Clot retention
0.00%
0/103 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
1.1%
1/93 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
General disorders
Perinephric hematoma
0.00%
0/103 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
1.1%
1/93 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
General disorders
Fatigue
0.00%
0/103 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
2.2%
2/93 • Number of events 2 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
Renal and urinary disorders
Stress urinary incontinence
0.97%
1/103 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
0.00%
0/93 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
General disorders
Pain: Abdominal colic
0.97%
1/103 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
3.2%
3/93 • Number of events 3 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
0.00%
0/103 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
1.1%
1/93 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
General disorders
Pain: Discomfort
0.97%
1/103 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
0.00%
0/93 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
Renal and urinary disorders
Pain: Dysuria
2.9%
3/103 • Number of events 3 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
5.4%
5/93 • Number of events 5 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
General disorders
Pain: Flank pain, bilateral
0.97%
1/103 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
0.00%
0/93 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
General disorders
Pain: flank pain, ipsilateral
6.8%
7/103 • Number of events 8 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
6.5%
6/93 • Number of events 7 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
Renal and urinary disorders
Pain: Ipsilateral ureteral pain
0.00%
0/103 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
1.1%
1/93 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
Renal and urinary disorders
Pain: stent pain
1.9%
2/103 • Number of events 2 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
0.00%
0/93 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
General disorders
Pain: PACU Right abdominal pain
0.00%
0/103 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
1.1%
1/93 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
Reproductive system and breast disorders
Pain: Other
0.00%
0/103 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
1.1%
1/93 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
Renal and urinary disorders
Pain: Post-op bladder / pelvic pain
0.97%
1/103 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
0.00%
0/93 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
General disorders
Pain: Post-op penile pain
0.00%
0/103 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
1.1%
1/93 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
General disorders
Pain: flank pain unspecified laterality
0.97%
1/103 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
0.00%
0/93 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
General disorders
Pain: surgical pain
0.97%
1/103 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
1.1%
1/93 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
Renal and urinary disorders
Pain: Ureteral meatus
0.00%
0/103 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
1.1%
1/93 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
General disorders
Pain involved with stent placement / removal and possible dislodging
1.9%
2/103 • Number of events 2 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
3.2%
3/93 • Number of events 3 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
General disorders
Pain: renal colic
0.97%
1/103 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
2.2%
2/93 • Number of events 2 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
Musculoskeletal and connective tissue disorders
Pain: Spinal pain
0.97%
1/103 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
0.00%
0/93 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
Respiratory, thoracic and mediastinal disorders
Bronchitis
0.00%
0/103 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
1.1%
1/93 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
Respiratory, thoracic and mediastinal disorders
Shortness of breath
0.00%
0/103 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
1.1%
1/93 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
Renal and urinary disorders
Altered creatinine levels
0.97%
1/103 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
0.00%
0/93 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
Renal and urinary disorders
Hematuria
0.97%
1/103 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
0.00%
0/93 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
Renal and urinary disorders
Hydronephrosis
2.9%
3/103 • Number of events 3 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
3.2%
3/93 • Number of events 3 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
Renal and urinary disorders
Hydroureter
0.00%
0/103 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
1.1%
1/93 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
Renal and urinary disorders
Worsening urinary urge incontinence
0.00%
0/103 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
1.1%
1/93 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
Renal and urinary disorders
Bladder spasms
0.00%
0/103 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
2.2%
2/93 • Number of events 2 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
Renal and urinary disorders
Meateal stenosis
0.00%
0/103 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
1.1%
1/93 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
Renal and urinary disorders
Pelvic pressure
0.00%
0/103 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
1.1%
1/93 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
Renal and urinary disorders
Urinary frequency
1.9%
2/103 • Number of events 2 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
0.00%
0/93 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
Renal and urinary disorders
Urinary urgency
0.97%
1/103 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).
1.1%
1/93 • Number of events 1 • 30 days (+ 14 days)
Follow up period was 30 days (+ 14 days). Only subjects with new or worsening hydronephrosis (from baseline) or ongoing SAEs at day 30 were followed through day 90 (+/- 21 days).

Additional Information

VP of RA / QA / CA

Avvio Medical, Inc.

Phone: 4158872037

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: GT60