Randall's Plaque Study: Pathogenesis and Relationship to Nephrolithiasis
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|ClinicalTrials.gov Identifier: NCT00169806|
Recruitment Status : Recruiting
First Posted : September 15, 2005
Last Update Posted : February 15, 2018
Kidney stones are very common. They affect 3-5% of the population in the United States. Many people are hospitalized for the treatment of kidney stones and some may die. Better understanding of what causes kidney stones is useful in both the treatment and prevention of kidney stones. However, exactly what causes kidney stones is unknown.
The most common type of kidney stones contains calcium, which sometimes is attached to a part of the kidney important in producing the final urine, called the papilla. The investigators have noticed that persons who form kidney stones seem to have more papilla with stones attached. They propose to study these areas of the papilla, called Randall's plaques (named after their discoverer), in patients undergoing surgery for kidney stones.
|Condition or disease||Intervention/treatment||Phase|
|Nephrocalcinosis Renal Calculi Hypercalciuria Hyperparathyroidism Cystinuria||Other: videotape for mapping of renal anatomy and papillary biopsy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randall's Plaques: Pathogenesis and Relationship to Nephrolithiasis|
|Study Start Date :||November 1998|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Subjects who are scheduled to undergo a percutaneous kidney stone removal who do not have complicated comorbidities
Other: videotape for mapping of renal anatomy and papillary biopsy
Subjects who enroll in this study will have their renal anatomy videotaped for mapping purposes. Stone location and characteristics will be documented as will papilla and calyces. One or more papillary biopsies will be taken for analysis.
- To find out why people form stones by comparing 24 urine collections, biopsy and anatomy to other patients who do not form stones and other patients who do form stones to see if the differences are significant [ Time Frame: One year from study completion ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00169806
|Contact: Lori Rawlings, RNemail@example.com|
|United States, Indiana|
|IU Health Methodist Hospital||Recruiting|
|Indianapolis, Indiana, United States, 46202|
|Contact: Lori Rawlings, RN 317-962-0870 firstname.lastname@example.org|
|Principal Investigator: James Lingeman, MD|
|Principal Investigator:||James Lingeman, MD||IU Health Physicians Urology|