Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT03195920
Status:
TERMINATED
Last Update Posted:
2024-04-17
First Post:
2017-06-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility Study of an Enhanced Lithotripsy System in the Treatment of Urinary Stone Disease
Sponsor:
Avvio Medical
Organization:
Study Overview
Official Title:
Feasibility Study of an Enhanced Lithotripsy System in the Treatment of Urinary Stone Disease
Status:
TERMINATED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Interim data was sufficient for study purpose
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: