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

NCT03195920 | Terminated FDA Device

• 1 other identifier: 2017-02
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Stone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Successful treatment of urinary stone

  14 days after last treatment session

Other Outcomes (3)

• Change in pain score

  Baseline and Post Procedure Days 1, 2, 3, 7, 14, and 30

• Time to passage of stones

  30 days after last treatment session

• Pain medication usage

  Baseline and Days 1, 2, 3, 7, 14, and 30

Study Arms (1)

Enhanced Lithotripsy System

EXPERIMENTAL

Treatment for urinary stones with the Enhanced Lithotripsy System

Device: Enhanced Lithotripsy System

Interventions

Enhanced Lithotripsy System DEVICE

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.

Enhanced Lithotripsy System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Avvio Medical: lead

Study Sites (1)

Muljibhai Patel Urological Hospital

Nadiād, Gujarat, 387 001, India

Location

MeSH Terms

Conditions

Urinary Calculi

Condition Hierarchy (Ancestors)

Urolithiasis; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Mahesh Desai, MS, FRCS

  Muljibhai Patel Urological Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single arm trial with the Enhanced Lithotripsy System

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 22, 2017
• Study Start: July 22, 2017
• Primary Completion: June 25, 2018
• Study Completion: October 5, 2022
• Last Updated: April 17, 2024

Record last verified: 2024-04

Locations

IN (1)