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.
94 studies on the registry are indexed under Urinary Calculi; 20 are open to participants now.
This study's enrollment of 3 is below the median of 120 across 61 interventional studies indexed under Urinary Calculi.
Browse Urinary Calculi studies →Avvio Medical is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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