A prospective randomized controlled trial of a single-use alloy-coated ureteral stent catheter set for temporary internal drainage of the ureter

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300071685

Enrollment

Unknown

Registered

2023-05-22

Start date

2023-06-01

Completion date

Unknown

Last updated

2023-06-12

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

Conditions

kidney stones, ureteral calculi

Interventions

test group:Use a single-use alloy-coated ureteral stent catheter

control group:Use a ureteral stent(Bard Healthcare Science (SHANGHAI) Co., Ltd.)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Over 18 years old, regardless of gender; 2. Patients with kidney stones and ureteral calculi who choose temporary ureteral internal drainage; 3. Volunteer to participate in the trial and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. Have a clear history of allergies to polyurethane and gold-silver-palladium alloy coating materials; 3. Patients with urothelial carcinoma; 4. Patients with malignant tumors invading the bladder; 5. Bladder dysfunction or lower urinary tract obstruction; 6. According to the investigator's judgment, the subject has other factors that are not suitable for participating in the trial, such as poor compliance.

Design outcomes

Primary

Measure	Time frame
stent drainage patency;	—

Secondary

Measure	Time frame
intubation success rate;drainage duration;laboratory test indicators;bacterial colonization rates of urine and scaffolds;	—

Countries

China

Contacts

Public ContactPu Xiaoyong

Guangdong Provincial People's Hospital

pryurol@163.com+86 138 0882 5388

Outcome results

None listed

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