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To evaluate the effectiveness and safety of Tulium-doped laser in the treatment of urinary calculi: a prospective, multi-center, single-group target clinical trial

To evaluate the effectiveness and safety of Tulium-doped laser in the treatment of urinary calculi: a prospective, multi-center, single-group target clinical trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047265
Enrollment
Unknown
Registered
2021-06-11
Start date
2021-07-05
Completion date
Unknown
Last updated
2022-02-01

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

Conditions

Urolithiasis

Interventions

Experimental group:Tulium-doped laser crushed stone

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years (inclusive), gender unlimited; 2. In the screening stage, the imaging examination indicated urinary calculus and the calculi were to be treated by endoscope; 3. Volunteered to participate in the clinical trial, and signed the informed consent of the subjects.

Exclusion criteria

Exclusion criteria: 1. Complicated with active, systemic or infectious diseases; 2. Patients with severe urinary tract infection, anesthesia intolerance and other surgical contraindications; 3. People who are known to be allergic to product materials; 4. People with mental illness or medical history; 5. Pregnant and lactating women and those who plan to become pregnant within 6 months; 6. The investigator considers it inappropriate to participate in the clinical trial.

Design outcomes

Primary

MeasureTime frame
one time successful rate of lithotripsy;

Secondary

MeasureTime frame
vital signs;adverse event;The amount of intraoperative bleeding;

Countries

China

Contacts

Public ContactXu Kewei

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

xukewei@mail.sysu.edu.com+86 13632331628

Outcome results

None listed

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