Clinical trial NCT03339388: Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stone Disease
Official title: Multi-Center Feasibility Study of Enhanced Lithotripsy System (ELS) in The Treatment of Urinary Stone Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Urinary Stone
Keywords: lithotripsy
urinary stone
Lead sponsor: Avvio Medical
Sponsor class: INDUSTRY
First posted: 2017-11-13
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Detailed description: 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. Subjects will be treated up to 2 times with the Enhanced Lithotripsy System and followed for 90 days after the last treatment session.

Eligibility criteria: 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

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.

Primary outcomes:
measure: Proportion of study participants with Serious Device and/or Serious Procedure-Related Adverse Events (Safety)
timeFrame: 90 days
Secondary outcomes:
measure: Stone-free status
timeFrame: 30 days
Other outcomes:
measure: Pain medication usage
timeFrame: 30 days
measure: Time to stone passage
timeFrame: 30 days
measure: Pain scoring
timeFrame: 30 days
Locations:
city: Campbelltown
country: Australia
facility: McArthur Urology
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Private Hospital
state: New South Wales
city: Bendigo
country: Australia
facility: Goldfields Urology
state: Victoria
city: Melbourne
country: Australia
facility: Austin Health
state: Victoria
Study officials:
affiliation: Austin Hospital, Melbourne Australia
name: Damien M Bolton, MD, MBBS
role: PRINCIPAL_INVESTIGATOR
References: