Acoustic Enhancer Research on Laser Lithotripsy (AEROLITH) (AEROLITH)
Primary Purpose
Urinary Stones
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ureteroscopy Laser Lithotripsy (URS-LL) with Acoustic Enhancer
Standard Ureteroscopic Laser Lithotripsy
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Stones focused on measuring Fragmentation of calcium-based urinary stones, Fragmentation of urinary stones
Eligibility Criteria
Inclusion Criteria:
- Male or female aged ≥ 18 years to ≤ 75 years
- Provides written informed consent
- 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.
- 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.
- Patients with bilateral stones are allowed but only one side may be treated. Only the treated side will be evaluated for safety and effectiveness
- Patients may enter the study with a stent in place.
- Patients presenting with absence of a Urinary Tract Infection as confirmed using urinalysis
Exclusion Criteria:
- 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.
- Patients with ureteral stones located distal to the iliac vessels on the side to be treated
- Diagnosis of radiolucent stones (on the side to be treated) on KUB or Scout CT Imaging
- 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)
- Patients who have had prior URS-LL within 3 months on the side to be treated at the time of consent.
- History of cystinuria
- Urine pH is < 5.5.
- Patients with known history of recurrent uric acid stones
- Untreated urinary tract infection (UTI)
- History of drug-resistant chronic UTI
- If female, pregnant as confirmed using urine test to be conducted on the day of the procedure.
- Patient has an American Society of Anesthesiologists (ASA) physical classification level of 4 or greater.
- 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
- Stones suspected in calyceal diverticula
- Horseshoe kidney
- Congenitally ectopic pelvic kidneys
- Full staghorn calculi >2cm
- Patients with elevated serum creatinine > 1.5mg/dl
- Patients with a solitary kidney
- Malrotated kidney on the side with urinary stone
- Duplicated collecting system or duplicated ureters
- 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
- Patients who are actively taking antiplatelet and anti-coagulation except low dose aspirin
- Prostate biopsy within the last 3 months
- History of radiation therapy of abdomen and pelvis
- History of urinary tract reconstruction
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.)
Sites / Locations
- University of Alabama
- Arizona Urology Specialists (Previously Arizona Institute of Urology, PLLC)
- Arkansas Urology Research Center
- University of California
- University of California
- University of California
- University of Florida
- University of Miami Health
- Northwestern University
- University of Kansas Medical Center
- Wichita Urology Group
- Ocshner LSU Health Shreveport - Regional Urology
- Chesapeake Urology Research Associates
- Brigham and Womens Hospital
- Michigan Institute of Urology
- Mount Sinai West
- SUNY Upstate Medical University
- Oregon Health and Sciences University
- MidLantic Urology
- Penn State Milton S. Hershey Medical Center
- Carolina Urologic Research Center
- Baylor College of Medicine
- Urology San Antonio
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ureteroscopic Laser Lithotripsy with Acoustic Enhancer
Standard Ureteroscopic Laser Lithotripsy
Arm Description
Ureteroscopic Laser Lithotripsy with Acoustic Enhancer
Standard Ureteroscopic Laser Lithotripsy
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT04563039
First Posted
September 15, 2020
Last Updated
April 3, 2023
Sponsor
Applaud Medical, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04563039
Brief Title
Acoustic Enhancer Research on Laser Lithotripsy (AEROLITH)
Acronym
AEROLITH
Official Title
Evaluation of Applaud Medical's Acoustic Enhancer With Laser Lithotripsy System in the Treatment of Urinary Stones
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 21, 2021 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Applaud Medical, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Stones
Keywords
Fragmentation of calcium-based urinary stones, Fragmentation of urinary stones
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
196 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ureteroscopic Laser Lithotripsy with Acoustic Enhancer
Arm Type
Experimental
Arm Description
Ureteroscopic Laser Lithotripsy with Acoustic Enhancer
Arm Title
Standard Ureteroscopic Laser Lithotripsy
Arm Type
Active Comparator
Arm Description
Standard Ureteroscopic Laser Lithotripsy
Intervention Type
Device
Intervention Name(s)
Ureteroscopy Laser Lithotripsy (URS-LL) with Acoustic Enhancer
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Standard Ureteroscopic Laser Lithotripsy
Intervention Description
Standard of care Ureteroscopic Laser Lithotripsy
Primary Outcome Measure Information:
Title
Efficacy: Absence of or have residual fragments measuring less </= to 2 mm
Description
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
Secondary Outcome Measure Information:
Title
Safety: Total Radiant Energy Used in the Treatment
Description
Total radiant energy is defined as mean value of laser energy that will be measured for each study arm
Time Frame
At 30 days post index procedure
Other Pre-specified Outcome Measures:
Title
Safety: Measurement of Lasering Time During Treatment
Description
Total lasering time will be evaluated for each study arm
Time Frame
At 30 days post index procedure
Title
Efficacy: Proportion of study subjects undergoing additional interventional stone treatment
Description
Proportion of subjects receiving additional intervention following treatment with either the Acoustic Enhancer with URS-LL or standard URS-LL
Time Frame
Through 90 days post index procedure
Title
Safety: Proportion of Adverse Events
Description
Device, procedure, device and procedure related adverse events as well as severity of each adverse event will be measured for each subject
Time Frame
Through 90 days post index procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female aged ≥ 18 years to ≤ 75 years
Provides written informed consent
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.
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.
Patients with bilateral stones are allowed but only one side may be treated. Only the treated side will be evaluated for safety and effectiveness
Patients may enter the study with a stent in place.
Patients presenting with absence of a Urinary Tract Infection as confirmed using urinalysis
Exclusion Criteria:
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.
Patients with ureteral stones located distal to the iliac vessels on the side to be treated
Diagnosis of radiolucent stones (on the side to be treated) on KUB or Scout CT Imaging
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)
Patients who have had prior URS-LL within 3 months on the side to be treated at the time of consent.
History of cystinuria
Urine pH is < 5.5.
Patients with known history of recurrent uric acid stones
Untreated urinary tract infection (UTI)
History of drug-resistant chronic UTI
If female, pregnant as confirmed using urine test to be conducted on the day of the procedure.
Patient has an American Society of Anesthesiologists (ASA) physical classification level of 4 or greater.
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
Stones suspected in calyceal diverticula
Horseshoe kidney
Congenitally ectopic pelvic kidneys
Full staghorn calculi >2cm
Patients with elevated serum creatinine > 1.5mg/dl
Patients with a solitary kidney
Malrotated kidney on the side with urinary stone
Duplicated collecting system or duplicated ureters
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
Patients who are actively taking antiplatelet and anti-coagulation except low dose aspirin
Prostate biopsy within the last 3 months
History of radiation therapy of abdomen and pelvis
History of urinary tract reconstruction
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tessa Yamut
Organizational Affiliation
Applaud Medical, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Arizona Urology Specialists (Previously Arizona Institute of Urology, PLLC)
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Arkansas Urology Research Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
University of California
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
University of California
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
University of California
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
University of Miami Health
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Wichita Urology Group
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Facility Name
Ocshner LSU Health Shreveport - Regional Urology
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Chesapeake Urology Research Associates
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Brigham and Womens Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Michigan Institute of Urology
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
Mount Sinai West
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Oregon Health and Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
MidLantic Urology
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Urology San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Acoustic Enhancer Research on Laser Lithotripsy (AEROLITH)
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