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A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of ALLN-177 Treatment Over 28 Days in Patients With Secondary Hyperoxaluria and Kidney Stones
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
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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A Phase 2b, Multi-Center, Randomized, Double Blind, Placebo-Controlled, Crossover Study to Evaluate Multiple Doses of ALLN-177 in Recurrent Calcium Oxalate Kidney Stone Formers with Hyperoxaluria
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
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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A Phase 3 Multicenter Trial Evaluating the Efficacy and Safety of MitoGel™ on Ablation of Upper Urinary Tract Urothelial Carcinoma (Olympus)
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The study is investigating the ability of UroGen's MitoGel™ procedure to treat urothelial carcinoma tumors from the upper urinary tract. If this treatment will prove to be effective this will lead to the development of a new treatment approach for patients suffering from Low Grade Upper Urinary Urothelial Carcinoma (UTUC).
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A Prospective Randomized Multicenter Trial Comparing Performance of Two Intracorporeal Lithotripters for Removal of Large Renal Calculi
Scottsdale/Phoenix, Ariz.
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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A Prospective, Multicenter, Post-Market Clinical Registry to Collect Real World Evidence on the Clinical Performance of SOLTIVE Laser for Treatment of Kidney or Ureteral Stones: SOLTIVE Clinical Registry
Scottsdale/Phoenix, Ariz.
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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Boston Scientific Double-J PLUS Ureteral Stent Postmarket Patient Registry
Scottsdale/Phoenix, Ariz.
The purpose of this study is to obtain postmarket safety and efficacy data on Boston Scientific Double-J Ureteral Stents.
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Collection of Blood and Urine in Healthy Patients
Scottsdale/Phoenix, Ariz.
The purpose of this study is to create a group of blood and urine samples from Mayo Clinic patients being screened for the kidney donor program as well as to collect risk factor data through a questionnaire. The data, blood and urine samples will be used for future research of kidney diseases at Mayo Clinic and future research at Mayo Clinic to learn about, prevent, or treat other health problems.
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Evaluate the Safety and Efficacy of ALLN-177 in Patients With Enteric Hyperoxaluria: A Phase III Randomized, Placebo-Controlled Study
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.
The purpose of this study is to determine the efficacy and safety of ALLN-177 in patients with enteric hyperoxaluria.
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Flexiva Pulse Laser Fiber Post-Market Patient Registry
Scottsdale/Phoenix, Ariz.
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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Investigation of Non-Invasive Hydration Monitoring with Smart Water Bottle to Increase Fluid Intake in Patients with Nephrolithiasis and Low Urine Volume
Scottsdale/Phoenix, Ariz.,
Rochester, Minn.
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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Patient Experience in Treatment for Low-grade Upper Tract Urothelial Carcinoma
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
to identify, describe, and substantiate important and relevant concepts related to (1) the signs, symptoms, and impacts of Low grade upper tract urothelial carcinoma (LG UTUC); (2) treatment burden and patients’ current treatment experiences for LG UTUC; and (3) perceptions of UGN-101, a novel topical chemotherapy for LG UTUC treatment, from the perspective of US-based adults with LG UTUC.
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Prospective Trial of a Reusable Digital Flexible Ureteroscope vs a Single-Use Flexible Ureteroscope in the Treatment of Urolithiasis: An EDGE Consortium Clinical Trial
Scottsdale/Phoenix, Ariz.
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. Goal of 90 patients divided between multiple sites.
Scottsdale/Phoenix, Ariz.
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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The EDGE Consortium: A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Percutaneous Nephrolithotomy: Part 1
Scottsdale/Phoenix, Ariz.
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 to < 24 hours of perioperative IV antibiotics only. We will then compare the rates of infectious complications following PCNL for the two groups.
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The EDGE Consortium: A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Percutaneous Nephrolithotomy: Part 1
Scottsdale/Phoenix, Ariz.
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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Ureteroscopic Treatment of Intrarenal Stones - A Comparative Analysis of Dusting Versus Basketing With Holmium Laser Lithotripsy
Scottsdale/Phoenix, Ariz.,
Rochester, Minn.
The purpose of this study is to evaluate outcomes of an established procedure for treatment of kidney stones that are present within the inner aspect of the kidney. This procedure is called flexible ureteroscopy, which involves placing a small camera through the urethra while anesthetized (asleep), up the ureter (the tube connecting kidney and bladder) and into the kidney to the kidney stone. Then, the stone is broken into tiny fragments using a small laser called a Holmium laser. While this treatment is a well-established option for treatment of these stones, there are several different techniques used to help eliminate them from the kidney. Some urologists treat the stone by a method called "active" extraction whereby the ureteroscope is passed back and forth into the kidney to remove all visible stone fragments. Others use a method called "dusting" whereby the stones are broken into tiny fragments or "dust" with the intention that achieving such a small stone size will allow the stones to pass spontaneously. There has not been a systematic and rigorous comparison of these techniques in terms of treatment outcomes. By collecting information on the success of treatment, the investigators hope to provide benchmark data for future studies of kidney stone treatment and improve the care of all patients who need surgery for their kidney stones. The investigators hypothesize that the stone free rate for renal stone(s) 5-15 mm is around 90% and that the stone clearance rate with be 20% higher in those patients that undergo complete stone fragment extraction versus those that undergo stone dusting (residual fragments < 2mm).
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Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II (WATERII)
Scottsdale/Phoenix, Ariz.
Single-arm, interventional pivotal clinical trial collecting patient data from use of the AQUABEAM System, a personalized image-guided waterjet resection system that utilizes a high-velocity saline stream to resect and remove prostate tissue in males suffering from Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH).The primary endpoints for safety and effectiveness will be measured at 3 months post-treatment. All treated subjects will be followed out to 12 months to collect long-term clinical data.
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