Comparing Super Pulse Fiber Thulium Laser and Holmium Laser for Ureteral Stone Fragmentation During Ureteroscopy

NCT06667557 | Recruiting

• 1 other identifier: IIT2024-147
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective, multicenter, randomized controlled trial is to objectively evaluate the clinical efficacy and safety differences between superpulse thulium fiber laser (sTFL) and holmium:YAG laser (Ho:YAG) in flexible ureteroscopy (FURS) lithotripsy in adult patients aged 18-70 years with kidney stones and/or upper ureteral stones (6-20mm). The main questions it aims to answer are: Does sTFL yield a higher stone-free rate (SFR) compared to Ho:YAG at 3 months post-FURS? Is sTFL superior to Ho:YAG in terms of operation time, complication rate, and surgeon's visual experience during FURS? Researchers will compare the experimental group receiving sTFL treatment to the control group receiving Ho:YAG laser treatment to see if sTFL demonstrates better lithotripsy efficiency, safety, and ease of operation. Participants aged 18-70 years will: Undergo FURS lithotripsy under general anesthesia using either sTFL (experimental group) or Ho:YAG laser (control group) based on randomization Have CT scans at 3 months post-operation to assess stone-free status Be monitored for intraoperative and postoperative complications Have surgeons rate their visual experience during the procedure in terms of visual clarity, lithotripsy efficiency, stone movement and tissue injury

Conditions

Kidney Calculi

Outcome Measures

Primary Outcomes (1)

• Stone-free Rate

  The proportion of participants achieving complete stone clearance, defined as no residual fragments or residual fragments ≤2 mm on follow-up imaging (e.g., plain radiography, ultrasound, or computed tomography) after a single laser lithotripsy procedure.

  3 months post-procedure

Secondary Outcomes (3)

• Operative Time

  Measured during the procedure

• Complication Rate

  From the start of the procedure until 24 hours post-procedure

• Surgeon's Visual Experience

  Measured immediately after the procedure

Study Arms (2)

sTFL Group

Kidney stones and/or upper ureteral stones are treated with a superpulsed thulium fiber laser (sTFL)

Device: Superpulse Thulium Fiber Laser (sTFL) Treatment

Ho:YAG Group

Kidney stones and/or upper ureteral stones are treated with a holmium :YAG laser (Ho:YAG)

Device: Holmium:YAG Laser (Ho:YAG) Treatment

Interventions

Superpulse Thulium Fiber Laser (sTFL) Treatment DEVICE

The superpulse thulium fiber laser (sTFL) was used as a minimally invasive surgical treatment for kidney and upper ureteral stones. All procedures were performed by experienced urologists using standard techniques for laser lithotripsy. Laser settings, such as pulse energy and frequency, were adjusted according to stone characteristics and the surgeon's judgment to optimize treatment efficacy and safety.

sTFL Group

Holmium:YAG Laser (Ho:YAG) Treatment DEVICE

The holmium:YAG laser (Ho:YAG) was used as a minimally invasive surgical treatment for kidney and upper ureteral stones. All procedures were performed by experienced urologists using standard techniques for laser lithotripsy. Laser settings, such as pulse energy and frequency, were adjusted according to stone characteristics and the surgeon's judgment to optimize treatment efficacy and safety.

Ho:YAG Group

Eligibility Criteria

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

Study Population

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

You may qualify if:

• Age ≥18 years old
• Diagnosis of kidney stones and/or upper ureteral stones with stone diameter ≥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 indicating that the patient or his or her legal representative has been fully informed about the study and has consented to participate

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
• Surgical completion under epidural anesthesia or lumbar anesthesia
• Recurrent stones due to genetic metabolic diseases

Sponsors & Collaborators

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

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 201620, China

RECRUITING

MeSH Terms

Conditions

Kidney Calculi

Interventions

Therapeutics

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

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: January 20, 2025
• Primary Completion (Estimated): October 20, 2027
• Study Completion (Estimated): October 20, 2028
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)