An interventional study of FURS with manual irrigation and FURS with automated irrigation in Renal Stone Disease, sponsored by Tanta University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Tanta University · Not applicable, Interventional, and Treatment
The Elephant II represents a second-generation flexible and navigable suction UAS. It is available in different calibers and incorporates a flexible distal segment that facilitates navigation with the ureteroscope. Compared with earlier-generation devices, the second-generation Elephant II incorporates a more flexible tip, an improved water-sealing cap, and an enhanced pressure-control module designed to facilitate more consistent suction without requiring continuous manual thumb control.
The development of the Elephant IV represents a further technological evolution toward intelligent pressure-controlled suction during RIRS. Unlike earlier suction-only systems, the newer generation integrates intrarenal pressure monitoring and automated pressure-control mechanisms, allowing irrigation and suction to be dynamically adjusted according to the measured intrarenal pressure. Such an approach may provide a more standardized and physiologically controlled operative environment, potentially avoiding both excessive intrarenal pressure and unnecessarily aggressive suction.
Therefore, a direct comparison between Elephant II and Elephant IV UASs during RIRS is clinically relevant. Such a study could determine whether the incorporation of real-time intrarenal pressure monitoring and automated pressure regulation translates into measurable improvements in intrarenal pressure control, endoscopic visibility, stone-free rate, irrigation/suction performance, and postoperative infectious and other complications.
The aim of this work is to compare the efficacy and safety of automated intrarenal irrigation during retrograde intrarenal surgery (RIRS) versus the manual hand-operated irrigation.
Tanta University is the lead sponsor of 1,010 studies on the registry; 321 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Procedure: FURS with manual irrigation
Procedure: FURS with automated irrigation
FURS with manual hand-operated irrigation
FURS with automated pressure-controlled irrigation
• Stone-free rate (fragments ≤2 mm)
Time frame: Up to 4 weeks postoperatively
Postoperative infectious complications (fever, SIRS or sepsis)
Time frame: Perioperative/Periprocedural
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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