Acoustic Enhancer Research on Laser Lithotripsy (AEROLITH)

Urinary Stones Clinical Trial

— AEROLITH  

Official title:

Evaluation of Applaud Medical's Acoustic Enhancer With Laser Lithotripsy System in the Treatment of Urinary Stones

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04563039
• Other study ID #: CIP-0001
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 21, 2021
• Est. completion date: August 2024

Study information

• Verified date: April 2024
• Source: Applaud Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 196
• Est. completion date: August 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Urinary Calculi
• Urinary Stones
• Urolithiasis

Intervention

Device:
• 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 of care Ureteroscopic Laser Lithotripsy

Locations

Country	Name	City	State
United States	MidLantic Urology	Bala-Cynwyd	Pennsylvania
United States	Chesapeake Urology Research Associates	Baltimore	Maryland
United States	University of Alabama	Birmingham	Alabama
United States	Brigham and Womens Hospital	Boston	Massachusetts
United States	Northwestern University	Chicago	Illinois
United States	University of Florida	Gainesville	Florida
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Baylor College of Medicine	Houston	Texas
United States	University of California	Irvine	California
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Arkansas Urology Research Center	Little Rock	Arkansas
United States	University of Miami Health	Miami	Florida
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Mount Sinai West	New York	New York
United States	Oregon Health and Sciences University	Portland	Oregon
United States	Urology San Antonio	San Antonio	Texas
United States	University of California	San Diego	California
United States	University of California	San Francisco	California
United States	Ocshner LSU Health Shreveport - Regional Urology	Shreveport	Louisiana
United States	SUNY Upstate Medical University	Syracuse	New York
United States	Michigan Institute of Urology	Troy	Michigan
United States	Arizona Urology Specialists (Previously Arizona Institute of Urology, PLLC)	Tucson	Arizona
United States	Wichita Urology Group	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Applaud Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety: Measurement of Lasering Time During Treatment	Total lasering time will be evaluated for each study arm	At 30 days post index procedure
Other	Efficacy: Proportion of study subjects undergoing additional interventional stone treatment	Proportion of subjects receiving additional intervention following treatment with either the Acoustic Enhancer with URS-LL or standard URS-LL	Through 90 days post index procedure
Other	Safety: Proportion of Adverse Events	Device, procedure, device and procedure related adverse events as well as severity of each adverse event will be measured for each subject	Through 90 days post index procedure
Primary	Efficacy: 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	At 30 days post index procedure
Secondary	Safety: Total Radiant Energy Used in the Treatment	Total radiant energy is defined as mean value of laser energy that will be measured for each study arm	At 30 days post index procedure