Nephrolithiasis Clinical Trial
Official title:
Kidney Stone Structural Analysis by Helical Computed Tomography (A Pilot Study)
Verified date | December 2011 |
Source | Indiana Kidney Stone Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
Current practices of the diagnosis of urinary stones gives little information on the probable fragility of stones using shock wave lithotripsy (SWL), and many patients receive more SW's than is necessary to break up their stones. Indeed, some patients are treated with SWL when their stones cannot be fragmented using this technology. The investigators have ample evidence that computed tomography (CT) images of kidney stones can reveal significant internal structure in stones—structure that is likely to be useful in predicting stone fragility—but no one has explored the use of clinical helical CT for this purpose. Also, the investigators do not know the effect that the human body wall and kidney tissue will have on the resolution of kidney stone structure with helical CT.
Status | Completed |
Enrollment | 7 |
Est. completion date | August 2011 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: In order to be eligible, patients must meet the following inclusion criteria: - Male and female kidney stone patients of IU Health Physicians Urology in Indianapolis, IN requiring a computed tomography scan prior to their stone surgical treatment (extracorporeal shock wave lithotripsy [ESWL], percutaneous nephrolithotomy, ureteroscopy) - Eligible patients must be able to suspend respiration for at least 20 seconds. The patient will be asked to perform a respiration suspension test for 20 seconds before recruitment. Exclusion Criteria: - Women in whom the potential for pregnancy has not been excluded are not eligible. A pregnancy test will be performed if necessary. - Inability to give informed consent - A previous history of abdominal malignancy |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | IU Health Methodist Hospital | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana Kidney Stone Institute | Indiana University School of Medicine, National Kidney Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine whether available clinical helical CT is able to reveal internal structure of kidney stones | Post op day one | No | |
Secondary | To determine if high resolution CT can differentiate between plaque and renal calculi. | Post op day one | No |
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