Skip to content

A prospective, multicenter, randomized, parallel controlled, non inferiority clinical trial to evaluate the efficacy and safety of Tm: Fiber laser therapeutic machine in the clinical application of urinary stone lithotripsy

A prospective, multicenter, randomized, parallel controlled, non inferiority clinical trial to evaluate the efficacy and safety of Tm: Fiber laser therapeutic machine in the clinical application of urinary stone lithotripsy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064944
Enrollment
Unknown
Registered
2022-10-24
Start date
2022-01-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Urolithiasis

Interventions

Experimental group:Tm: fiber
Control group:Ho:YAG

Sponsors

Sir Run Run Shaw Hospital of Zhejiang University Medical College
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. 18~75 years old, regardless of gender; 2. Patients with urolithiasis (bladder stone, ureteral stone, kidney stone) indicated by imaging (CT); 3. Holmium laser lithotripsy or thulium laser lithotripsy for urinary calculi through cystoscope, percutaneous nephroscope, ureterorenoscope (hard) or ureterorenoscope; 4. Volunteer to participate in this trial, be willing to complete follow-up visits, and sign a written informed consent.

Exclusion criteria

Exclusion criteria: 1. Untreated renal tuberculosis or uncontrolled urinary tract infection; 2. Combined with malignant tumor of urinary system; 3. Patients with severe ureteral distortion, ureteral stricture and difficult to enter the endoscope due to various reasons; 4. Percutaneous nephrolithotripsy is planned, and it is inconvenient to establish channels because the distance between the waist and kidney exceeds 20cm or the high kidney is accompanied by splenomegaly/hepatomegaly; 5. Pregnant or planned pregnant and lactating women in the last 6 months; 6. Those who have participated in other clinical trials in recent 3 months; 7. The researcher believes that it is not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Stone-free rate;

Countries

China

Contacts

Public ContactLi Gonghui

Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine

3193119@zju.edu.cn+86 13588708507

Outcome results

None listed

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