ILY Robotic System vs Manual Flexible Ureteroscopy for Kidney Stone Treatment

Официальное название

A Randomized Controlled Trial Comparing Efficacy, Ergonomics, and Safety of ILY Robotic System vs Manual Flexible Ureteroscopy in Patients Undergoing Laser Lithotripsy for Kidney Stones

Обзор

The goal of this clinical trial is to compare the efficacy, ergonomics, and safety of robotic versus manual flexible ureteroscopy (fURS) for kidney stone treatment in adult patients undergoing laser lithotripsy. * Does robotic-assisted lithotripsy using the ILY® robot have the same efficacy as the manual fURS in treating kidney stones? * Is robotic flexible ureteroscopy associated with similar or improved safety outcomes, including perioperative and 30-day postoperative complication rates? * Does the robotic system offer improved ergonomics, lower surgeon radiation exposure, and favorable intraoperative metrics compared to manual flexible ureteroscopy? Researchers will compare the ILY robotic system with manual fURS to see if robotic intervention can match or improve clinical and ergonomic outcomes. Participants will: * Be randomly assigned to undergo laser lithotripsy with either the ILY robot or manual flexible ureteroscopy * Complete standard pre- and postoperative assessments * Undergo evaluation for stone-free status using a non-contrast CT scan at 30 days postoperatively * Undergo evaluation for postoperative complications

Вмешательства

• Процедура Robotic-Assisted Flexible Ureteroscopy
  Use of the ILY® robotic system to perform flexible ureteroscopy.
• Процедура Manual Flexible Ureteroscopy
  Conventional flexible ureteroscopy performed manually by the surgeon.

Первичные конечные точки

• Efficacy assessed by measuring the stone-free rate (SFR) [Срок оценки: 30 days after the index procedure]

Вторичные конечные точки (5)

• Perioperative and 30-day Postoperative Outcomes [Срок оценки: Perioperatively and 30 days after the procedure]
• Ergonomics [Срок оценки: Immediately after the procedure]
• Surgeon safety in terms of radiation exposure [Срок оценки: During the procedure]
• Intraoperative Parameters [Срок оценки: During the procedure]
• Conversion rate [Срок оценки: During the procedure]

Критерии участия

Критерии включения

• Males or females ≥ 18 years old
• Patients with a normal pelvicalyceal anatomy
• Patients with renal stone diagnosis confirmed by noncontrast computed tomography regardless of stone size, location, and multiplicity
• ASA score I-III
• Intact mental and cognitive ability to provide informed consent and willingness to participate in the study with 30-day follow-up

Критерии исключения

• Children < 18 and pregnant women
• Patients with anatomically anomalous kidneys, known case of stricture or stenosis, or recent 3-month history of ureteroscopy (DJ stent placement only will be accepted) or known history of complicated ureteroscopy
• Patients in whom stone measurement was not feasible on NCCT or those with concomitant ureteric stones.
• ASA score IV
• Mentally incapacitated patients unable to provide informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Ливан · 1 центр

• American University of Beirut Medical Center — Beirut

Идентификаторы

NCT: NCT06996587 · BIO-2024-0452

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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