New Laser and Suction Sheath for Kidney Stone Treatment

NCT06667466 | Not Yet Recruiting

• 1 other identifier: IIT2024-148
• Study Type: observational
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Stone free rate

  The proportion of patients with no residual stone or with residual stone diameter less than 2mm, as determined by non - contrast CT scan. This measure is used to evaluate the effectiveness of the two treatment methods in completely removing the stones.

  3 months postoperatively

Secondary Outcomes (2)

• time of operation

  During the surgical procedure

• Complication

  During the surgical procedure and within 24 hours after the surgical procedure

Study Arms (2)

sTFL + Flexible Negative-Pressure UAS

Under general anesthesia, a guidewire is first inserted. Then, the Flexible Negative Pressure UAS is inserted along the guidewire to the stone site. A ureteroscope is inserted through the sheath to the stone site. The sTFL is used to fragment the stone with a power setting of 0.8J and a frequency of 12 - 20Hz. Simultaneously, the fragmented stones are removed by negative pressure suction.

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

sTFL + Conventional UAS

Under general anesthesia, the Conventional UAS is inserted to the upper ureter or the ureteropelvic junction. A ureteroscope is inserted through the sheath to the stone site. The sTFT is used to fragment the stone with a power setting of 0.8J and a frequency of 12 - 20Hz. After fragmentation, the stones are removed by a stone basket.

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

Interventions

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

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.

sTFL + Conventional UAS

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

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.

sTFL + Flexible Negative-Pressure UAS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients aged 18-70 years who plan to undergo ureteral soft endoscopic (fURS) lithotripsy for kidney stones and/or ureteral stones (6-20mm)

You may qualify if:

• Age ≥18 years old.
• Diagnosed with kidney stones and/or ureteral stones, and stone diameter is ≥6mm and ≤20mm
• Plan to undergo fURS lithotripsy
• General anesthesia to complete the operation
• The latest urine culture before surgery is negative
• Signed and dated informed consent

You may not qualify if:

• Isolated kidney
• Previous history of kidney transplantation or urinary diversion surgery
• Congenital malformations of urinary system
• Abnormal coagulation mechanism due to blood system diseases, liver diseases, etc
• Severe heart or lung disease, malignancy and immune deficiency status
• Neurogenic bladder
• Failure to provide informed consent
• Have an untreated urinary tract infection
• The presence of known anatomic abnormalities (such as ureteral stenosis), urothelial tumors, or stones that can be removed directly without the use of laser lithotripsy
• Pregnant women
• In cases where the stone cannot be reached with a bendable negative pressure suction sheath, or in cases where the stone cannot be reached with a conventional sheath or the pyeloureteral junction
• Epidural anesthesia or lumbar anesthesia to complete the operation

Sponsors & Collaborators

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

MeSH Terms

Conditions

Kidney Calculi; Ureteral Calculi

Interventions

Methods

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Ureterolithiasis; Ureteral Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Yi Shao

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruixuan Zhu

CONTACT

+86 13780820139; luluzhu2023@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: October 31, 2024
• Study Start (Estimated): November 20, 2026
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): November 20, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01