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Nephrolithiasis clinical trials

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NCT ID: NCT06394908 Enrolling by invitation - Urolithiasis Clinical Trials

Registry of MIUS for Urolithiasis (ReMIUS-U)

ReMIUS-U
Start date: May 10, 2023
Phase:
Study type: Observational [Patient Registry]

The purpose of this registry is to collect data on patients who have undergone minimally invasive treatments for urinary system stone disease, including percutaneous nephrolithotomy (PCNL), shock wave lithotripsy (SWL), semi-rigid ureterorenoscopy (URS), and flexible ureterorenoscopy (F-URS).

NCT ID: NCT06320860 Enrolling by invitation - Kidney Calculi Clinical Trials

FlexStone Enabled Kidney Stone Retrieval

Start date: March 8, 2024
Phase: N/A
Study type: Interventional

This study investigates if additional basket control in helpful during retrieval of kidney stones especially those that are difficult to reach for standard baskets.

NCT ID: NCT06266793 Enrolling by invitation - Nephrolithiasis Clinical Trials

Comparison of Holmium Laser and Thulium Laser for Mini PCNL

HOTLaser
Start date: March 7, 2024
Phase: N/A
Study type: Interventional

This is a single institution, single surgeon, randomized controlled trial to evaluate the Boston Scientific Lumenis Pulse 120H Moses 2.0 holmium laser versus the Olympus Soltive Superpulsed thulium fiber laser (TFL) for medium-to-large stones in the mini PCNL setting.

NCT ID: NCT06070714 Enrolling by invitation - Renal Stone Clinical Trials

Efficiency and Safety of Holmium Laser With Moses Technology Versus SuperPulsed Laser System With Thulium Fiber Laser on Renal Stones

Start date: September 7, 2023
Phase: N/A
Study type: Interventional

This is a prospective randomized controlled trial designed to assess the efficacy and safety of Lumenis® Pulse™ P120H holmium laser system with the Moses technology (holmium laser with pulse modulation) versus the Soltive™ SuperPulsed Laser System with the thulium fiber laser (thulium fiber laser), in dusting of renal stones during ureteroscopy with laser lithotripsy. 310 participants will be enrolled across 5 research sites.

NCT ID: NCT04746378 Enrolling by invitation - Urolithiasis Clinical Trials

PRedictive Accuracy of Initial Stone Burden Evaluation.

PRAISE
Start date: September 9, 2021
Phase:
Study type: Observational

This study is intended to be a prospective registry of patients undergoing any kind of stone treatment that have a pre-operative CT available. This imaging will be used to measure the stone burden in three different ways: in a single dimension (cumulative stone diameter), in two dimensions (surface area) and in three dimensions (volume).The primary purpose is to identify what way of measuring stone burden is most predictive of outcomes after stone treatment such as stone free status, operative time and complications.

NCT ID: NCT04575480 Enrolling by invitation - Ideal Time Interval Clinical Trials

The Ideal Time Interval Between Repeated Shock Wave Lithotripsy Sessions For Renal Stones: A Randomized Controlled Trial

Start date: July 15, 2020
Phase: N/A
Study type: Interventional

There is no consensus about the required time intervals between repeated SWL sessions applied for renal stones with some centers waiting for 3 days, others for one week and others up to one month to repeat lithotripsy. In the 2019 EUA guidelines stated that "There are no conclusive data on the intervals required between repeated SWL sessions. However, clinical experience indicates that repeat sessions are feasible (within 1 day for ureteral stones). The intense use of ESWL currently, the lack of knowledge about acute lesions caused by re-treatment within a short time interval and the empirical way by which treatment is conducted, stimulated us to search for a precise answers to the question What the ideal time interval between SWL sessions in the treatment of renal stone patients should be. This randomized controlled trial will be conducted at Urology and Nephrology Center in Mansoura, Egypt. Patients more than 18 years old with single primary renal stone fulfilling inclusion criteria will be randomly allocated to 3 groups (50 patients each).Group 1 will undergo SWL with 3 days between each session. Group 2 will undergo SWL with 7 days between each session and Group 3 will undergo SWL with 14 days between each session. Study parameters will be renal damage including the following items: - Tubular damage will be assessed through estimation of changes in urinary excretion of renal tubular enzyme kidney injury molecule 1(KIM-1). - Glomerular damage will be assessed by estimation of proteinuria and changes in GFR calculated by renal isotope scan. - Renal morphological and haemodynamic changes. - Treatment success is defined as clinically insignificant residual fragments less than 4 mm size.

NCT ID: NCT04071340 Enrolling by invitation - Renal Stone Clinical Trials

The Natural History of Minimally Symptomatic Nonobstructing Calyceal Stones

Start date: September 1, 2019
Phase:
Study type: Observational

- The primary aim is to study the natural history of single-calyx asymptomatic nonobstructing stone disease. - The Secondary aim is to determine the predictors of the need for intervention and of cure in such population.

NCT ID: NCT03229889 Enrolling by invitation - Nephrolithiasis Clinical Trials

Trial of Tadalafil, Tamsulosin and Combination for Access Sheath Deployment

Start date: June 7, 2017
Phase: Phase 4
Study type: Interventional

Extensive literature exists on the use of alpha-blocker medications for the removal of kidney stones. Alpha blockers relax certain muscles and help small blood vessels remain open. They work by keeping the hormone norepinephrine (noradrenaline) from tightening the muscles in the walls of smaller arteries and veins, which causes the vessels to remain open and relaxed. This improves blood flow and lowers blood pressure. There are studies that demonstrate alpha-blockers decrease ureteral pressure and help the ureter "relax." Recent studies have shown that phosphodiesterase inhibitors may also help with ureteral stone passing. A phosphodiesterase inhibitor is a drug that blocks an enzyme that inhibits relaxation of smooth muscle. This means that it can help smooth muscle, such as the muscle that lines the ureter, to relax. While ureteral relaxation is helpful in the passage of ureteral stones, our study seeks to use this finding by pretreating participants with an older generation alpha blocker or a phosphodiesterase inhibitor prior to passage of a ureteral access sheath in cases in which ureteroscopy is being used to approach a ureteral or renal stone. By relaxing the ureter, it is possible that a larger access sheath can be safely placed. This may allow for facilitating passage of the ureteroscope and extraction of stone fragments while precluding the development of potentially damaging intrarenal pressure from the flow of irrigant. The ureteral access sheath also protects the ureter from damage during the procedure. Placement of the largest access sheath possible is helpful in that larger stone fragments can be retrieved, the flow of irrigant is improved, and the surgical field is kept clear of blood or debris. To date, nobody has studied whether use of an uro-selective alpha blocker, alone, or in combination with a 5 phosphodiesterase inhibitor will result in passage of larger access sheaths. In this study participants will be randomized into 1 of 4 categories: Flomax (alpha-blocker), Cialis (5-phosphodiesterase inhibitor), a combination of the 2, or a placebo arm. In this study the placebo, or no active drug, is the current standard of care and will serve as a control from the other 3 groups.

NCT ID: NCT02434068 Enrolling by invitation - Kidney Calculi Clinical Trials

Assessment of Flexible Ureteroscopy Residual Fragments

Start date: March 2015
Phase: N/A
Study type: Observational

Residual fragments of urinary calculi after flexible ureteroscopy (URF) can cause symptoms and additional surgeries. The assessment of residual fragments by imaging is not standardized. Computed tomography (CT) is the best way for evaluation of urinary stones, however, ionizing radiation from CT is deleterious. The aim of this study is to define which patients may avoid CT for evaluation of residual fragments after URF. 115 patients with > 18 years old undergoing URF for kidney stone < 20 mm or < 15 mm in the lower calyx diagnosed by CT will be studied. The clinical evaluation of patients will be held by the same urologist in pre-operative consultation, 7 days after the procedure, 30 days after the procedure and 100 days after the procedure. The assessment of residual fragments will be made through TC, ultrasound and Kidney-bladder-ureter KUB 90 days after the procedure. The image methods for residual fragments assessment will be compared by Cochran Test and prediction of parameters to avoid CT will be made by multiple logistic regression, using IPSS 16.0, with significant level of 5%.

NCT ID: NCT02408211 Enrolling by invitation - Kidney Stones Clinical Trials

Preoperative Antibiotic PNL Study

Start date: March 2015
Phase: Phase 4
Study type: Interventional

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.