An interventional study of Enhanced Lithotripsy System in Urinary Stone, sponsored by Avvio Medical. Terminated at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-17.
Sponsored by Avvio Medical · Not applicable, Interventional, and Device feasibility
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.
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.
Exclusion Criteria:
Treatment for urinary stones with the Enhanced Lithotripsy System
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.
Proportion of subjects with serious device-related adverse events (safety)
Safety: Proportion of subjects with serious device-related adverse events
Time frame: 30 days after last treatment session
Successful treatment of urinary stone
Proportion of subjects with successful treatment or urinary stone
Time frame: 14 days after last treatment session
Change in pain score
Pelvic Pain of the Patient (Min - Zero, Max - 10), Higher score means more pain
Time frame: Baseline and Post Procedure Days 1, 2, 3, 7, 14, and 30
Time to passage of stones
Post-Treatment time to passage of stone fragments after treatment
Time frame: 30 days after last treatment session
Pain medication usage
Use and quantity of pain medication
Time frame: Baseline and Days 1, 2, 3, 7, 14, and 30
Plan to share: Undecided
No publications or documents are linked to this record.
This study is terminated, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Avvio Medical