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The Effect of Different Body Positions and Channel Sheaths on RIRS

StatusUnknown
PhaseNot applicable
Started
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Record status
This record was last updated September 24, 2024 (before its estimated November 2024 completion). Its status may not reflect the trial's current state.

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Enrollment target: 90 to 120v2 Show 4 more changesShow less
    • Primary completion date: May 2025 to Nov 2024
    • Study completion date: Jul 2025 to Nov 2024
    • Interventions: RIRS with f-UAS, lateral position (Procedure), RIRS with f-UAS, lithotomy position (Procedure), RIRS with traditional UAS, lithotomy… to RIRS with f-UAS, lateral position (Procedure), RIRS with f-UAS, lithotomy position (Procedure), RIRS with traditional UAS, lateral position…
    • Study arms: 3 to 4
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Retrograde flexible ureteroscopy (RIRS) is currently the first-line treatment for renal stones \< 2cm. Lower pole renal stones(LPS) are a difficult problem for urologists. The flexible negative pressure suction ureteral sheath(f-UAS) can facilitate RIRS to flush out the fragments and dust in time, and provide a clear vision and reduce the renal pelvis pressure(RPP) during operation.Standard lithotomy position is the most commonly used position for RIRS. Besides, T-tilt position is also available for RIRS in special cases. Investigators were inspired by this and proposed the lateral position, which is available in cases of LPS.In long-term practice, investigators have found that the change of position and the use of f-UAS can improve stone-free rate(SFR). Investigators aimed to conduct a prospective randomized controlled trial to compare the SFR of different positions and different ureteral sheaths.
Trial Details
NCT Number NCT06438497
Lead Sponsor The First Affiliated Hospital of Guangzhou Medical University
Conditions
(from sponsor)		 Urolithiasis
Related terms Urolithiasis
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov