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

NCT03195920 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2024-04-17

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Avvio Medical

    lead INDUSTRY

Principal Investigators

  • Mahesh Desai, MS, FRCS · Muljibhai Patel Urological Hospital

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-22
Primary Completion
2018-06-25
Completion
2022-10-05
FDA Device
Yes

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03195920 on ClinicalTrials.gov