An interventional study of Enhanced Lithotripsy System in Urinary Stone, sponsored by Avvio Medical. Terminated at 4 sites in Australia. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-04-17.
Sponsored by Avvio Medical · Not applicable, Interventional, and Device feasibility
This is a single arm, multi-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, multi-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 90 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 13 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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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 of urinary stones with the Enhanced Lithotripsy System
Device: Enhanced Lithotripsy System
Stone treatment with the Enhanced Lithotripsy System
Proportion of study participants with Serious Device and/or Serious Procedure-Related Adverse Events (Safety)
Incidence of Serious Device and/or Serious Procedure-Related adverse events
Time frame: 90 days
Stone-free status
Proportion of study participants who are successfully treated \[absence of stones or with only clinically-insignificant remaining fragments\]
Time frame: 30 days
Pain medication usage
Collection of pain concomitant pain medications
Time frame: 30 days
Time to stone passage
Evaluation of stone presence
Time frame: 30 days
Pain scoring
Patient reported pain scores
Time frame: 30 days
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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