Feasibility Study of an Enhanced Lithotripsy System in the Treatment of Urinary Stone Disease

Urinary Stone Clinical Trial

Official title:

Feasibility Study of an Enhanced Lithotripsy System in the Treatment of Urinary Stone Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03195920
• Other study ID #: 2017-02
• Status: Terminated
• Phase: N/A
• Start date: July 22, 2017
• Est. completion date: October 5, 2022

Study information

• Verified date: April 2024
• Source: Applaud Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: October 5, 2022
• Est. primary completion date: June 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urinary Calculi
• Urinary Stone
• Urolithiasis

Intervention

Device:
• 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.

Locations

Country	Name	City	State
India	Muljibhai Patel Urological Hospital	Nadiad	Gujarat

Sponsors (1)

Lead Sponsor	Collaborator
Applaud Medical, Inc.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in pain score	Pelvic Pain of the Patient (Min - Zero, Max - 10), Higher score means more pain	Baseline and Post Procedure Days 1, 2, 3, 7, 14, and 30
Other	Time to passage of stones	Post-Treatment time to passage of stone fragments after treatment	30 days after last treatment session
Other	Pain medication usage	Use and quantity of pain medication	Baseline and Days 1, 2, 3, 7, 14, and 30
Primary	Proportion of subjects with serious device-related adverse events (safety)	Safety: Proportion of subjects with serious device-related adverse events	30 days after last treatment session
Secondary	Successful treatment of urinary stone	Proportion of subjects with successful treatment or urinary stone	14 days after last treatment session