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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03339388




Registration number
NCT03339388
Ethics application status
Date submitted
7/11/2017
Date registered
13/11/2017
Date last updated
17/04/2024

Titles & IDs
Public title
Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stone Disease
Scientific title
Multi-Center Feasibility Study of Enhanced Lithotripsy System (ELS) in The Treatment of Urinary Stone Disease
Secondary ID [1] 0 0
2017-03
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urinary Stone 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Enhanced Lithotripsy System

Experimental: Enhanced Lithotripsy System - Treatment of urinary stones with the Enhanced Lithotripsy System


Treatment: Devices: Enhanced Lithotripsy System
Stone treatment with the Enhanced Lithotripsy System
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of study participants with Serious Device and/or Serious Procedure-Related Adverse Events (Safety)
Timepoint [1] 0 0
90 days
Secondary outcome [1] 0 0
Stone-free status
Timepoint [1] 0 0
30 days

Eligibility
Key inclusion criteria
- Male or female aged = 18 years to = 75 years.

- One urinary stone-apparent on a computed tomography (CT) scan within 14 days prior to
study enrollment

- Stone size, as estimated by pre-procedure CT, with all dimensions 15 mm or less.

- Provides written informed consent

- Understands and accepts the study requirements
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Age less than 18 years of age or over 75 years of age

- Diagnosis of radiolucent stones

- Diagnosis of stones in the lower pole of kidney

- History of cystinuria

- Urine pH below 5.5

- Current untreated urinary tract infection

- Pregnancy

- Coagulation abnormality or taking prescription anticoagulants. Aspirin usage will be
discontinued at least 7 days prior to enrollment at the discretion of the attending
physician.

- Mobility issues - unable to comfortably lie still for up to 30 minutes or unable to
roll from back to side

- Known hypersensitivity to conductivity gel

- Vulnerable individuals (mentally disabled, physically disabled, prisoner, etc.)

- Body mass index greater than 35

- American Society of Anesthesiologists (ASA) score of 3 or greater general anesthesia
risk level

- Known sensitivity to possible medications used before, during, or after the ELS
procedure, including but not limited to the following: sedative agents, general
anaesthetics, topical anaesthetics, and opioid analgesics.

- Enrollment in another research study or previous participation within 30 days of
enrollment.

Study design
Purpose of the study
Device Feasibility
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/12/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/10/2022
Sample size
Target
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
McArthur Urology - Campbelltown
Recruitment hospital [2] 0 0
Westmead Private Hospital - Westmead
Recruitment hospital [3] 0 0
Goldfields Urology - Bendigo
Recruitment hospital [4] 0 0
Austin Health - Melbourne
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
3550 - Bendigo
Recruitment postcode(s) [4] 0 0
3084 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Applaud Medical, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a single arm, multi-center study to assess the safety and efficacy of a form of
extracorporeal lithotripsy, called the Enhanced Lithotripsy System, to treat urinary stones.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03339388
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Damien M Bolton, MD, MBBS
Address 0 0
Austin Hospital, Melbourne Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03339388