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A comparison on the outcomes of patients undergoing shockwave lithotripsy using the Storz machine versus the Dornier machine.
This is a single institution, prospective randomized controlled clinical trial comparing two lithotriper machines (the Storz Modulith LX-F2 and Dornier Delta III) in patients who are undergoing shockwave lithotripsy (SWL) as the primary management of their urinary stone. Patients record pain score on day of operation and post-operative day 1, and are followed for 1 month until they receive standard of care imaging at 1 month post-operatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device Storz Modulith SLX-F2 | Active Comparator | Patients receive standard of care treatment for their urolithiasis using the Device Storz Modulith SLX-F2 |
|
| Dornier Delta III Treatment | Active Comparator | Patients receive standard of care treatment for their urolithiasis using the Dornier Delta III lithotripter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lithotripter | Procedure | Patients receive standard of care treatment for their urolithiasis using one of two lithotripter machines |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stone free rate | Presence of stone on follow up imaging | Four weeks post operative |
| Measure | Description | Time Frame |
|---|---|---|
| Fluoroscopy time | Length of fluoroscopy exposure | Intra-operative |
| Treatment Time | Length of surgical procedure | Intra-operative |
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Inclusion Criteria:
- Cleveland Clinic Foundation patients planned for elective SWL with a preoperative CT performed
Patients must be capable of giving informed consent and must be capable and willing to enroll and participate fully with the study.
Exclusion Criteria:
Prior treatment for specified stone
Patients unable to give informed consent or unwilling to enroll or participate in the study will be excluded.
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| Name | Affiliation | Role |
|---|---|---|
| Manoj Monga, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| D014514 | Ureteral Calculi |
| D053039 | Ureterolithiasis |
| D052878 | Urolithiasis |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Pain Scores | Response to visual analog scale | Four days post-operative |
| Complication Rates | Medical complications | One month post-operative |
| Secondary Interventions required | Follow up surgery | One month post-operative |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014515 | Ureteral Diseases |