Urinary Stones
Conditions
Keywords
Fragmentation of calcium-based urinary stones, Fragmentation of urinary stones
Brief summary
A pivotal study to evaluate the safety and effectiveness of Applaud Acoustic Enhancer when used in conjunction with conventional ureteroscopic laser lithotripsy (URS-LL) in the treatment of subjects with urinary stones.
Detailed description
The AEROLITH Clinical Study will evaluate the safety and effectiveness of Applaud Acoustic Enhancer when used in conjunction with conventional ureteroscopic laser lithotripsy (URS-LL) in the treatment of subjects with urinary stones. The clinical study is a prospective, multi-center, two-arm, randomized, double blinded study. A total of 196 subjects will be enrolled in this study at up to 27 investigational sites located in the U.S.
Interventions
DEVICEUreteroscopy 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.
DEVICEStandard Ureteroscopic Laser Lithotripsy
Standard of care Ureteroscopic Laser Lithotripsy
Sponsors
Avvio Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
This study is a double blinded study in which study subjects will not be informed of their treatment allocation through the index procedure. In assessing stone fragmentation using a CT image as defined in the primary endpoint, an independent radiologist will conduct the assessment and will be blinded to the treatment allocation of each subject's CT image.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female aged ≥ 18 years to ≤ 75 years 2. Provides written informed consent 3. Patients with at least one urinary stone measuring 6mm or greater (but no more than a cumulative diameter of 20mm) located proximally to the iliac vessels on one side may be treated. 4. Urinary stone(s) should be apparent on a CT scan within 60 days prior to study enrollment. Stone assessment will be conducted using CT imaging following CLIN-0025: AEROLITH IDE Study Screening Guide. 5. Patients with bilateral stones are allowed but only one side may be treated. Only the treated side will be evaluated for safety and effectiveness 6. Patients may enter the study with a stent in place. 7. Patients presenting with absence of a Urinary Tract Infection as confirmed using urinalysis
Exclusion criteria
1. Patients with stones exceeding a cumulative diameter of 20mm on the side to be treated. Note: Punctate stones measuring ≤ 2mm do not count in the cumulative diameter limit. 2. Patients with ureteral stones located distal to the iliac vessels on the side to be treated 3. Diagnosis of radiolucent stones (on the side to be treated) on KUB or Scout CT Imaging 4. For patients who have a ureteral stent in place, patient is excluded if stent is calcified or encrusted as verified using standard of care imaging (e.g. KUB X-ray) 5. Patients who have had prior URS-LL within 3 months on the side to be treated at the time of consent. 6. History of cystinuria 7. Urine pH is \< 5.5. 8. Patients with known history of recurrent uric acid stones 9. Untreated urinary tract infection (UTI) 10. History of drug-resistant chronic UTI 11. If female, pregnant as confirmed using urine test to be conducted on the day of the procedure. 12. Patient has an American Society of Anesthesiologists (ASA) physical classification level of 4 or greater. 13. Known sensitivity to possible medications used before, during, or after the URS Laser Lithotripsy procedure, including but not limited to the following: sedative agents, general anesthetics, topical anesthetics, and opioid analgesics 14. Stones suspected in calyceal diverticula 15. Horseshoe kidney 16. Congenitally ectopic pelvic kidneys 17. Full staghorn calculi \>2cm 18. Patients with elevated serum creatinine \> 1.5mg/dl 19. Patients with a solitary kidney 20. Malrotated kidney on the side with urinary stone 21. Duplicated collecting system or duplicated ureters 22. Patients who are currently involved in any investigational drug or device trial or have been enrolled in such trials within 30 days of index procedure 23. Patients who are actively taking antiplatelet and anti-coagulation except low dose aspirin 24. Prostate biopsy within the last 3 months 25. History of radiation therapy of abdomen and pelvis 26. History of urinary tract reconstruction 27. Other factors that the investigator feels would interfere with the participation and completion of the study such as: * Inability to provide voluntary consent * Inability to understand the clinical investigation or cooperate with investigational procedures * Planned relocation or unable to return for required follow-up visits * Vulnerable individuals (mentally disabled, physically disabled, prisoner, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Absence of or Have Residual Fragments Measuring Less </= to 2 mm | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 103 |
| Standard Ureteroscopic Laser Lithotripsy Standard Ureteroscopic Laser Lithotripsy
Standard Ureteroscopic Laser Lithotripsy: Standard of care Ureteroscopic Laser Lithotripsy | 93 |
| Total | 196 |
Baseline characteristics
| Characteristic | Ureteroscopic Laser Lithotripsy With Acoustic Enhancer | Standard Ureteroscopic Laser Lithotripsy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 103 Participants | 93 Participants | 196 Participants |
| Age, Continuous | 50.8 years | 54.7 years | 52.7 years |
| BMI | 31.183 kg/m^2 | 30.785 kg/m^2 | 30.994 kg/m^2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants | 14 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 85 Participants | 79 Participants | 164 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 103 participants | 93 participants | 196 participants |
| Sex: Female, Male Female | 52 Participants | 46 Participants | 98 Participants |
| Sex: Female, Male Male | 51 Participants | 47 Participants | 98 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 103 | 0 / 93 |
| other Total, other adverse events | 36 / 103 | 43 / 93 |
| serious Total, serious adverse events | 4 / 103 | 5 / 93 |
Outcome results
Primary
Number of Participants With Absence of or Have Residual Fragments Measuring Less </= to 2 mm
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
Time frame: At 30 days post index procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ureteroscopic Laser Lithotripsy With Acoustic Enhancer | Number of Participants With Absence of or Have Residual Fragments Measuring Less </= to 2 mm | 41 participants |
| Standard Ureteroscopic Laser Lithotripsy | Number of Participants With Absence of or Have Residual Fragments Measuring Less </= to 2 mm | 42 participants |