NCT03195920

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Avvio Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Stone

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-07-22
• Primary completion: 2018-06-25
• Completion: 2022-10-05
• First posted: 2017-06-22
• Last updated: 2024-04-17

Locations

1 site across 1 country: India

Regulatory

• FDA-regulated device study