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Interim data was sufficient for study purpose
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Lithotripsy System | Experimental | Treatment for urinary stones with the Enhanced Lithotripsy System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced Lithotripsy System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with serious device-related adverse events (safety) | Safety: Proportion of subjects with serious device-related adverse events | 30 days after last treatment session |
| Measure | Description | Time Frame |
|---|---|---|
| Successful treatment of urinary stone | Proportion of subjects with successful treatment or urinary stone | 14 days after last treatment session |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain score | Pelvic Pain of the Patient (Min - Zero, Max - 10), Higher score means more pain | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mahesh Desai, MS, FRCS | Muljibhai Patel Urological Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Muljibhai Patel Urological Hospital | Nadiād | Gujarat | 387 001 | India |
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| ID | Term |
|---|---|
| D014545 | Urinary Calculi |
| ID | Term |
|---|---|
| D052878 | Urolithiasis |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Single arm trial with the Enhanced Lithotripsy System
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| 30 days after last treatment session |
| Pain medication usage | Use and quantity of pain medication | Baseline and Days 1, 2, 3, 7, 14, and 30 |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |