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Preoperative Antibiotic PNL Study
Scottsdale/Phoenix, AZ
Percutaneous nephrolithotomy (PCNL) is a surgical procedure that is standard of care for the removal of large kidney stones. PCNL involves removal of the stone(s) from the kidney through a temporary tract that is percutaneously placed through the patient's back during surgery. There is a significant risk of urinary tract infection after PCNL but wide clinical variation in use of prophylactic antibiotics in the days leading up to surgery. For patients who had already agreed to undergo PCNL, we plan to randomize them either to 1 week of preoperative antibiotic prophylaxis plus < 24 hours of perioperative IV antibiotics or ...
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Dual Energy CT for Determining Kidney Stone Composition
Jacksonville, FL
The primary focus of this minimal risk study will be to assess and refine the ability of DE CT to accurately determine kidney stone composition.
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Pain From Non-obstructing Stones
Scottsdale/Phoenix, AZ
A prospective study to determine if the removal of non-obstructing renal calculi can reduce or eliminate participant's pain and/or improve their quality of life.
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Comparison of Laser Lithotripsy With and Without Steerable Ureteroscopic Renal Evacuation (SURE)
Scottsdale/Phoenix, AZ
The purpose of the study is to compare the effects, good and/or bad, of a treatment for removing kidney stones called the SURE procedure for stone evacuation to the standard treatment using a basket for stone removal.
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A Study to Evaluate Effectiveness of Preventing Urinary Stones With Hydration
Rochester, MN
The purpose of this trial is to investigate the impact of increased fluid intake and increased urine output on the recurrence rate of urinary stone disease (USD) in adults and children. The primary aim of the trial is to determine whether a multi‐component program of behavioral interventions to increase fluid intake will result in reduced risk of stone disease progression over a 2‐year period.
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A Study of the Use of Preoperative Antibiotics Given Preventively Prior to Kidney Stone Surgery to Patients at Moderate Risk of Infection
Scottsdale/Phoenix, AZ
The purpose of this study is to determine if the use of preoperative antibiotics given to prevent infection actually decreases the postoperative risk in patients having surgery to remove kidney stones.
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Evaluating Kidney Stones To Determine If They Lead to Kidney Disease
Rochester, MN
We hypothesize that clinical studies to investigate the role of individual proteins in kidney stone pathogenesis have likely been confounded by an unknown variety of underlying renal pathologies. Therefore, we propose to examine urinary protein crystallization inhibitors in patient populations that have been carefully phenotyped relative to renal stone precursor lesions by direct endoscopic visualization. In collaboration with Project #1, our second major goal is to use these accurately phenotyped patients in order to adapt modern dual-energy CT technology to develop a reliable noninvasive technique to accurately and noninvasively determine stone composition and visualize the earliest kidney stone precursor lesions. ...
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Monogenic Kidney Stone - Genetic Testing
Rochester, MN
90 genes related to Monogenic Stone Disease will be determined via DNA analysis by the Mayo Rare Kidney Stone Consortium (RKSC) research staff.
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A Study of Reusable Digital Flexible Ureteroscope vs a Single-Use Flexible Ureteroscope in the Treatment of Urolithiasis
Scottsdale/Phoenix, AZ
The purpose of this study is to determine if the performances of two types of scopes that are used to treat kidney stones are equivalent. This will help guide institutions in the future to purchase the best scopes for their patients.
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Randomized Controlled Trial to Compare the Operative Outcomes and Complications of Mini-Percutaneous Nephrolithotomy (mini-PCNL) Versus Standard PCNL
Scottsdale/Phoenix, AZ
The purpose of this study is to compare the operative outcomes and complications of mini-percutaneous nephrolithotomy (mini-PCNL) versus standard PCNL for renal stones.
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A Comparison of Ureteroscopic Treatment of Nephrolithiasis With and Without Moses Technology
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the potential of Moses laser technology to reduce operative time compared to non-Moses settings for ureteroscopic treatment of nephrolithiasis.
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A Study of the Ability for CT Imaging to Accurately Predict the Fragility (Quality of Being Easily Broken) of Kidney Stones during Surgical Intervention
Rochester, MN
A Study of the ability for CT imaging to accurately predict the fragility (quality of being easily broken) of kidney stones during surgical intervention.
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Predicting Stone Recurrence on CT Scan
Jacksonville, FL; Rochester, MN
The purpose of this study is to determine if models predicting symptomatic recurrence (Recurrence of Kidney Stones score) in the prospective cohort study (IRB #08-006541) also predict radiographic stone formation and growth among 300 incident stone formers at Mayo Clinic Rochester and 55 incident stone formers at Mayo Clinic Florida in our current prospective cohort.
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Health-related Quality of Life in Rare Kidney Stone
Rochester, MN
Assessment of Health-related Quality of Life in Rare Kidney Stone Formers in the Rare Kidney Stone Consortium
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A Study to Assess the Effectiveness of the Smart Water Bottle to Increase Fluid Intake in Patients with Kidney Stones and Low Urine Volume
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to assess the effectiveness of the Smart Water Bottle technology to monitor and increase fluid intake in patients with kidney stones and low urine output.
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Descriptive Analysis of Gut Microbiome Alterations in Hyperoxaluric Patients
Rochester, MN
To characterize the microbiome in 4 groups of subjects (primary hyperoxaluria type I (PH1), idiopathic CaOx stone, enteric hyperoxaluria (EH) and healthy participants) by comparing the number of species and diversity of the microbial populations and pathway for oxalate metabolism by paralleling the gene expression of enzymes involved in oxalate degradation by gut bacteria.
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Use of Tolvaptan to Reduce Urinary Supersaturation: a Pilot Proof of Principle Study
Rochester, MN
In this study the investigators propose to use a daily dose of 45 mg (30 mg at 8 AM and 15 mg at 4 PM). This relatively small well-tolerated dose is likely to persistently increase urine volume and reduce urine supersaturation and to be well tolerated by patients with kidney stone disease and normal renal function. The twice-daily (8 AM and 4 PM) regimen is designed to produce a maximal AVP inhibition on waking with a gradual fall-off of effect during the night. To this end, a higher dose is used in the morning, with a lower dose in the ...
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The Performance of the SOLTIVE™ Laser System for Laser Lithotripsy in Kidney or Ureteral Stones
Scottsdale/Phoenix, AZ
The purpose of this study is to collect real-world evidence on the performance of the SOLTIVE™ Premium SuperPulsed Laser System for laser lithotripsy in ureteroscopy, PCNL or mini PCNL for kidney and ureteral stones.
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Role Of Phosphorus And FGF 23 In Patients With Dent Disease
Rochester, MN
Patients with Dent disease have suppressed levels of FGF 23 which contributes to hypercalciuria, kidney stones, nephrocalcinosis and renal failure. Supplementation with phosphorus may reduce hypercalciuria.
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A Study to Form a Database of Children with Kidney Stone Disease
Rochester, MN
The purpose of this study is to establish a database to collect and analyze information on metabolic and environmental risk factors for kidney stone formation in children.
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Identification of Uric Acid Renal Stones Using Newer CT Technology
Rochester, MN
The purpose of this study is to compare the ability to identify uric acid renal stones between alternate CT scanning techniques and the current dual-source CT scanning technique.
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A Study to Compare ShockPulse-SE vs. Trilogy Lithotripters for Removal of Large Kidney Stones
Scottsdale/Phoenix, AZ
The purpose of this study is to measure how well two different devices work to break up and remove kidney stones. We are comparing a newer device to an older one to see which one is faster at breaking up kidney stones. We hypothesize that the Trilogy device will increase the stone clearance rate by 25% compared to the Shockpulse-SE device.
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Reducing Opioid Prescription After Kidney Stone Removal Surgery
Rochester, MN
Due to the ongoing opioid epidemic in the United States, there is increased attention and interest in reducing the use of opioid medication after surgery to minimize the risk of opioid tolerance and addiction, decrease the pool of unused opioids available for misuse, and maximize the use of alternative pain management medications and techniques. The purpose of this study is to implement and assess a standard way of prescribing opioids following percutaneous nephrolithotomy.
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A Study of the Frequency of Kidney Stone Formation in Liver Disease Patients
Jacksonville, FL
The purpose of this study is to compare the frequency of occurance of kidney stone formation in liver disease patients compared to the general population.
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A Study to Assess the Effect of Cannabidiol Oil on Pain After Ureteroscopy for Kidney stones
Scottsdale/Phoenix, AZ
The purpose of this study is to determine if CBD oil has any effect on decreasing postoperative pain control following ureteroscopy for urinary stone disease, and to determine if CBD oil has any effect in decreasing the amount of postoperative opioids (commonly used drug) used by patients after undergoing ureteroscopy for urinary stone disease.
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Epidemiology of Kidney Stones and Chronic Kidney Disease
Rochester, MN
By comparing people who have kidney stones to people who do not have kidney stones, we hope to learn what causes kidney stones to form and determine if kidney stones lead to loss of kidney function or kidney disease.
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Life Stories for Opioid Risk Reduction in the ED
Rochester, MN
The objective of this study is to compare the effectiveness of (A) a standardized general risk information sheet only, (B) a standardized general risk information sheet plus a probabilistic risk tool, (C) standardized sheet plus narrative enhanced probabilistic risk tool on a variety of patient reported and patient centered outcomes related to pain treatment and the risks and benefits of opioid prescriptions for common, acute pain conditions.
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A Study of Patients with Primary Hyperoxaluria Type 3 with a History of Stone Events
Rochester, MN
The objective of this study is to collect data on stone formation and the degree of nephrocalcinosis in patients (≥ 2 years of age) with genetically confirmed PH3 and relatively intact renal function and to explore the potential relationship between Uox and new stone formation.
This is a natural history study of adults, adolescents, and children (≥ 2 years of age) with genetically confirmed primary hyperoxaluria type 3 (PH3) who have a history of stone events during the last 3 years and/or the presence of pre-existing stones detected by renal ultrasound at Screening.
The relationship between the level of Uox and the ...
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Primary Hyperoxaluria Mutation Genotyping
Rochester, MN
This study will help us determine whether certain genetic mutations, more than others, are a cause of more severe disease in Primary Hyperoxaluria.
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A Study to Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients with Hyperoxaluria and Kidney Stones
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to evaluate the safety, tolerability, and effectiveness of different doses of ALLN 177 for reducing urinary oxalate excretion in patients with secondary hyperoxaluria and recurrent kidney stones.
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Rare Kidney Stone Consortium Patient Registry
Rochester, MN; Jacksonville, FL
The purpose of this study is to collect medical information from a large number of patients in many areas of the world with primary hyperoxaluria (PH), Dent disease, Cystinuria and APRT deficiency. This information will create a registry that will help us to compare similarities and differences in patients and their symptoms. The more patients we are able to enter into the registry, the more we will be able to understand the Primary Hyperoxalurias,Dent disease, cystinuria and APRT and learn better ways of caring for patients with these diseases.
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Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Secondary Hyperoxaluria and Kidney Stones Over 28 Days
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
Evaluate the safety, tolerability, and efficacy of 28 days of treatment with ALLN-177 for reducing urinary oxalate excretion in patients with secondary hyperoxaluria and kidney stones.
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Establishing the Safety and Effectiveness of Reloxaliase in Patients With Enteric Hyperoxaluria
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the effectiveness, durability, and long-term safety of Reloxaliase in patients with Enteric Hyperoxaluria.
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Biobank Protocol, Rare Diseases Clinical Research Network
Rochester, MN
This study is being done to obtain samples from patients with primary hyperoxaluria, cystinuria, adenine phosphoribosyl transferase (APRT) deficiency, and Dent disease, and from their family members, for use in future research.
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Flexiva Pulse Registry
Scottsdale/Phoenix, AZ
The purpose of this study is to obtain post-market safety and effectiveness data for FlexivaTM Pulse High Power Single-Use Laser Fibers during lithotripsy and soft tissue procedure of holmium laser enucleation of the prostate (HoLEP).
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A Study to Evaluate the Mechanisms Leading to Hyperoxaluria and Increased Risk of Kidney Stone Formation after Bariatric Surgery
Rochester, MN
This study aims to evaluate the mechanisms leading to hyperoxaluria and increased risk of kidney stone formation after bariatric surgery.
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Prospective Research Rare Kidney Stones
Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the natural history of the hereditary forms of nephrolithiasis and chronic kidney disease (CKD), primary hyperoxaluria (PH), cystinuria, Dent disease and adenine phosphoribosyltransferase deficiency (APRTd) and acquired enteric hyperoxaluria (EH). The investigator will measure blood and urinary markers of inflammation and determine relationship to the disease course. Cross-comparisons among the disorders will allow us to better evaluate mechanisms of renal dysfunction in these disorders.