Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology
NCT07101809
Calculi, Female Urogenital Diseases
Birmingham, Alabama, United States
View Trial DetailsNCT Number: NCT05297331
This is an international prospective data registry to assess the treatment outcomes and complications of different treatment approaches for different surgical treatment of urolithiasis.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Alice Ho Miu Ling Nethersole Hospital, Hong Kong
Renal stone is a common condition, and many patients suffered from recurrent diseases and required multiple interventions in their lifetime. Currently, there are many treatment options available for stone treatment, including shockwave lithotripsy, ureteroscopy, percutaneous nephrolithotomy etc.
Different treatment approaches will result in different treatment successful rate and also potential adverse effects to patients. The main challenge for stone management is the decision on the best treatment approach for individual stone of each patient. This is because for the same type of stone (such as lower caliceal stone or upper ureteric stone), different surgical treatment could be applied. The decision will depend on various patients (such as age, premorbid etc.) and stone factors (such as size, density etc) and also patients' preference.
New advances in technology have improved treatment outcomes for urolithiasis, such as single use flexible ureteroscopes, flexible and navigable ureteral access sheaths (FANS), direct in scope suction (DISS), intrarenal pressure (IRP) and intrarenal temperature (IRT) monitoring devices, new lasers and pulse modulation, etc.
Therefore, in order to have more information to guide treatment decision during discussion with patients, a prospective data registry is created to assess the treatment outcomes and complications of different treatment approaches in our hospital clusters. This information will be important for audit, treatment comparison and also patient education.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: postoperative, at 1 and/or 3 months
stone free rate
Time frame: intraoperative
Including irrigation and suction and laser settings and devices, laser consumption and efficacy, fluoroscopy dosage and time, equipment (ureteral access sheath size and lengths, ureteroscopy sizes, stone basket) utilised; exit strategy; intraoperative complications if noted; ergonomics
Time frame: Thirty days after the operation
The 30-day complications will be graded according to the Clavien-Dindo classification
Time frame: At 12 months
Stone recurrence rate
Time frame: preoperative, postoperative on day 0 and at follow up
Pain VAS scores and QOL assessment
Contact information is provided by the study sponsor or research team.
Chinese University of Hong Kong
Other
A Prospective Assessment of the Perioperative Parameter and Treatment Outcomes of Urinary Calculi - International Registry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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