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Study of an Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stone Disease
NA trial testing Enhanced Lithotripsy System in Urinary Stone in 25 participants. Terminated before completion.
| Lead sponsor | Avvio Medical |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | device feasibility |
| Enrollment | 25 |
| Start date | 8 February 2019 |
| Primary completion | 18 March 2020 |
| Estimated completion | 5 October 2022 |
| Sites | 4 locations across Australia |
Avvio Medical
Adults 18 to 75, any sex, with Urinary Stone. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Proportion of study participants who, after up to 2 ELS treatments, have a complete absence of stones or with any residual fragments measuring less than 3 mm in the largest dimension as assessed by follow-up imaging
| Group | Value | 95% CI |
|---|---|---|
| Enhanced Lithotripsy System | 17 |
Incidence of Serious Device and/or Serious Procedure-Related adverse events
| Group | Value | 95% CI |
|---|---|---|
| Enhanced Lithotripsy System | 4 |
Time frame: 30 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Enhanced Lithotripsy System |
|---|---|---|
| Pain: Flank Pain | General disorders | — |
| Paroxysmal Atrial Fibrillation | Cardiac disorders | — |
| Haematuria | Renal and urinary disorders | — |
| Myocardia Infarction | Cardiac disorders | — |
| Other: Fracture | Musculoskeletal and connective tissue disorders | — |
| Reaction | System | Enhanced Lithotripsy System |
|---|---|---|
| Pain: Flank Pain | General disorders | — |
| Intermittent Urinary Frequency | Renal and urinary disorders | — |
| Urinary Tract / bladder or other infection in the genitourinary system | Renal and urinary disorders | — |
| Hypotension | Cardiac disorders | — |
| Altered bowel problems | Gastrointestinal disorders | — |
| Pain, Other: Hip Pain | General disorders | — |
| Pain, Other: Left Groin Pain | General disorders | — |
| Glucose in Urine | Renal and urinary disorders | — |
| Haematuria | Renal and urinary disorders | — |
| Increased Urinary Frequency | Renal and urinary disorders | — |
| Retained Calculi | Renal and urinary disorders | — |
| Atrial Fibrillation | Cardiac disorders | — |
| Gastroesophageal Reflux Disease | Gastrointestinal disorders | — |
| Pain: Dysuria | General disorders | — |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | — |
| Altered Creatinine Levels | Renal and urinary disorders | — |
| Urethral Stricture | Renal and urinary disorders | — |
| Elevated Temperature | General disorders | — |
Most-reported serious reactions: Pain: Flank Pain, Paroxysmal Atrial Fibrillation, Haematuria, Myocardia Infarction, Other: Fracture.
Data from ClinicalTrials.gov NCT04771182 adverse events section.
This is a single arm, multi-center study to assess the safety and efficacy of a form of extracorporeally induced lithotripsy, called the Enhanced Lithotripsy System, to treat urinary stones.
No peer-reviewed publications indexed yet for this trial.
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