Skip to content

Prospective multi-center randomized controlled study of superpulsed thulium laser combined with bendable negative pressure suction sheath/conventional sheath for the treatment of kidney stones

Prospective multi-center randomized controlled study of superpulsed thulium laser combined with bendable negative pressure suction sheath/conventional sheath for the treatment of kidney stones

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090881
Enrollment
Unknown
Registered
2024-10-15
Start date
2024-10-16
Completion date
Unknown
Last updated
2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urolithiasis

Interventions

Group 1:Kidney stones and/or ureteral stones were treated with a superpulsed thulium fiber laser (sTFL) combined with a bendable negative pressure suction sheath
Group 2:Kidney stones and/or ureteral stones were treated with a superpulsed thulium fiber laser (sTFL) combined with a conventional sheath

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Age =18 years old; 2) Kidney stones and/or ureteral stones are diagnosed, and the stone diameter is =6mm; =20mm; 3) Plan to undergo fURS lithotripsy; 4) General anesthesia to complete the operation; 5) The latest urine culture before surgery was negative; 6) A 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

Exclusion criteria

Exclusion criteria: 1) Isolated kidney; 2) Previous history of kidney transplantation or urinary diversion surgery; 3) Congenital malformations of urinary system; 4) Abnormal coagulation mechanism due to blood system diseases, liver diseases, etc.; 5) severe heart or lung disease, malignancy and immune deficiency status; 6) Neurogenic bladder; 7) Failure to provide informed consent; 8) Have an untreated urinary tract infection; 9) 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; 10) Pregnant women 11) 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; 12)The procedure is done under epidural or lumbar anesthesia

Design outcomes

Primary

MeasureTime frame
Stone-Free Rate, SFR;

Secondary

MeasureTime frame
time of operation;complication;

Countries

China

Contacts

Public ContactYi Shan

Shanghai General Hospital

drshaoyi@163.com+86 136 6163 3372

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026