Feasibility Study of an Enhanced Lithotripsy System in the Treatment of Urinary Stone Disease
NCT ID: NCT03195920
Last Updated: 2024-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
3 participants
INTERVENTIONAL
2017-07-22
2022-10-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Enhanced Lithotripsy System
Treatment for urinary stones with the Enhanced Lithotripsy System
Enhanced Lithotripsy System
The Enhanced Lithotripsy System is a type of lithotripsy system comprising a console, treatment head, and Acoustic Energy Focusing material. Operation of the Enhanced Lithotripsy System entails combined action of extracorporeal insonation and Acoustic Energy Focusing material to fragment urinary stones.
Interventions
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Enhanced Lithotripsy System
The Enhanced Lithotripsy System is a type of lithotripsy system comprising a console, treatment head, and Acoustic Energy Focusing material. Operation of the Enhanced Lithotripsy System entails combined action of extracorporeal insonation and Acoustic Energy Focusing material to fragment urinary stones.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Avvio Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Mahesh Desai, MS, FRCS
Role: PRINCIPAL_INVESTIGATOR
Muljibhai Patel Urological Hospital
Locations
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Muljibhai Patel Urological Hospital
Nadiād, Gujarat, India
Countries
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Other Identifiers
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2017-02
Identifier Type: -
Identifier Source: org_study_id
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