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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.

  • 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.

  • 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.

  • Investigation of Non-Invasive Hydration Monitoring with Smart Water Bottle to Increase Fluid Intake in Patients with Nephrolithiasis and Low Urine Volume Rochester, Minn., Scottsdale/Phoenix, Ariz.

    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.

  • Patient Experience in Treatment for Low-grade Upper Tract Urothelial Carcinoma Scottsdale/Phoenix, Ariz., Jacksonville, Fla. 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.
  • The EDGE Consortium: A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Percutaneous Nephrolithotomy: Part 1 Scottsdale/Phoenix, Ariz., Rochester, Minn.

    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.

  • 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).

  • 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.