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New Laser and Suction Sheath for Kidney Stone Treatment

NCT06667466 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 140

Last updated 2026-01-21

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if the combination of super pulsed thulium fiber laser (sTFL) with a flexible negative pressure suction sheath is more effective and safer than sTFL with a conventional sheath in treating kidney stones and/or ureteral stones. The main questions it aims to answer are:

Does the sTFL with a flexible negative pressure suction sheath have a higher stone - free rate than the sTFL with a conventional sheath? Does the sTFL with a flexible negative pressure suction sheath have fewer complications than the sTFL with a conventional sheath?

Researchers will compare the two treatment groups to see if there are differences in stone - free rate and complication rates.

Participants will:

Undergo ureteroscopic lithotripsy surgery. In the experimental group, have a flexible negative pressure suction sheath inserted along a guidewire to the stone site under general anesthesia, then have a ureteroscope inserted through the sheath to the stone site, and have the stone fragmented by sTFL with a power setting of 0.8J and a frequency of 12 - 20Hz while the fragments are removed by negative pressure suction.

In the control group, have a conventional sheath inserted to the upper ureter or the ureteropelvic junction under general anesthesia, then have a ureteroscope inserted through the sheath to the stone site, and have the stone fragmented by sTFL with a power setting of 0.8J and a frequency of 12 - 20Hz and the fragments removed by a stone basket.

Conditions

  • Kidney Calculi
  • Ureteral Calculi

Interventions

DEVICE

Super Pulsed Thulium Fiber Laser (sTFL) + Flexible Negative Pressure Ureteral Access Sheath (UAS) Intervention

The intervention combines a Super Pulsed Thulium Fiber Laser (sTFL) with a power setting of 0.8J and a frequency of 12 - 20Hz for stone fragmentation and a Flexible Negative Pressure Ureteral Access Sheath (UAS) that allows access to the stone site and enables negative pressure suction for stone removal.

DEVICE

Super Pulsed Thulium Fiber Laser (sTFL) + Conventional Ureteral Access Sheath (UAS) Intervention

The intervention combines a Super Pulsed Thulium Fiber Laser (sTFL) with a power setting of 0.8J and a frequency of 12 - 20Hz for stone fragmentation and a Conventional Ureteral Access Sheath (UAS) used for access to the upper ureter or ureteropelvic junction for stone treatment.

Sponsors & Collaborators

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Yi Shao · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-20
Primary Completion
2026-11-20
Completion
2027-11-20

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06667466 on ClinicalTrials.gov