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

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

Sponsors

Lead sponsor: Applaud Medical, Inc.

Source Applaud Medical, Inc.
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.

Overall Status Terminated
Start Date July 22, 2017
Completion Date June 25, 2018
Primary Completion Date June 25, 2018
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Proportion of subjects with serious device-related adverse events (safety) 30 days after last treatment session
Secondary Outcome
Measure Time Frame
Successful treatment of urinary stone 14 days after last treatment session
Enrollment 3
Condition
Intervention

Intervention type: Device

Intervention name: Enhanced Lithotripsy System

Description: 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.

Arm group label: Enhanced Lithotripsy System

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Mahesh Desai, MS, FRCS Principal Investigator Muljibhai Patel Urological Hospital
Location
facility
Muljibhai Patel Urological Hospital
Location Countries

India

Verification Date

June 2018

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Enhanced Lithotripsy System

Arm group type: Experimental

Description: Treatment for urinary stones with the Enhanced Lithotripsy System

Patient Data Undecided
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Single arm trial with the Enhanced Lithotripsy System

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov