Clinical trial NCT03195920: Feasibility Study of an Enhanced Lithotripsy System in the Treatment of Urinary Stone Disease
Official title: Feasibility Study of an Enhanced Lithotripsy System in the Treatment of Urinary Stone Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Urinary Stone
Lead sponsor: Avvio Medical
Sponsor class: INDUSTRY
First posted: 2017-06-22
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm trial with the Enhanced Lithotripsy System
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This is a single arm, single 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, single 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 30 days after the last treatment session.

Eligibility criteria: Inclusion Criteria:

* Individuals presenting with one urinary stone-apparent on a computed tomography scan within the last 14 days
* Males and females aged 18 or older
* Capable of giving informed consent, and willing to have the informed consent process videotaped
* Stone size, as estimated by pre-operative computed tomography, with all dimensions 15 mm or less.

Exclusion Criteria:

* Individuals under 18 years of age
* Individuals with radiolucent stones
* Individuals with stones in the lower pole of kidney
* Individuals not following up in the treating hospital
* Individuals with history of cystinuria
* Individuals with urine pH below 5.5
* Individuals with untreated urinary tract infection
* Individuals who are not willing to use adequate method of contraception during the study period
* Women who are pregnant, lactating or planning pregnancy during the study period
* Individuals with a coagulation abnormality or taking prescription anticoagulants.
* Individuals with mobility issues who are unable to comfortably lie still for up to 30 minutes or roll from their back to their side
* Individuals belonging to a vulnerable group (pregnant, mentally disabled, physically disabled, prisoner, etc.)
* Individuals with a body mass index greater than 35
* Individuals with ASA score of 3 or greater general anesthesia risk level
* Known sensitivity to possible medications used before, during, or after the treatment procedure, including but not limited to the following: sedative agents, general anesthetics, topical anesthetics, and opioid analgesics

Primary outcomes:
measure: Proportion of subjects with serious device-related adverse events (safety)
timeFrame: 30 days after last treatment session
Secondary outcomes:
measure: Successful treatment of urinary stone
timeFrame: 14 days after last treatment session
Other outcomes:
measure: Change in pain score
timeFrame: Baseline and Post Procedure Days 1, 2, 3, 7, 14, and 30
measure: Time to passage of stones
timeFrame: 30 days after last treatment session
measure: Pain medication usage
timeFrame: Baseline and Days 1, 2, 3, 7, 14, and 30
Locations:
city: Nadiad
country: India
facility: Muljibhai Patel Urological Hospital
state: Gujarat
Study officials:
affiliation: Muljibhai Patel Urological Hospital
name: Mahesh Desai, MS, FRCS
role: PRINCIPAL_INVESTIGATOR
References: