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A clinical study to evaluate the safety, efficacy and maneuverability of a single-use flexible ureteropelvic endoscopy catheter for the observation, diagnosis and device-assisted treatment of lesions in the ureter, renal pelvis and calyx

A clinical study to evaluate the safety, efficacy and maneuverability of a single-use flexible ureteropelvic endoscopy catheter for the observation, diagnosis and device-assisted treatment of lesions in the ureter, renal pelvis and calyx

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100055012
Enrollment
Unknown
Registered
2021-12-30
Start date
2022-01-07
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

None listed

Interventions

experimental group: single-use flexible ureteropelvic endoscopy catheter

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Sign the informed consent; 2. Aged 18-70 years (including 18 and 70 years old), no gender limit; 3. Patients with upper urinary tract calculi diagnosed by imaging and in line with the indications for ureteroscopic lithotripsy; 4. Kidney or/and ureteral calculi diameter <= 2cm.

Exclusion criteria

Exclusion criteria: 1. The patient has participated in another clinical trial of drugs or medical devices within 3 months; 2. Patients with severe cardiopulmonary insufficiency, history of cerebrovascular accident, and inability to tolerate ureteroscopic lithotripsy; 3. Patients with severe urinary tract infection; 4. Those with abnormal coagulation function; 5. Severe urethral or ureteral stricture, severe deformity and abnormal renal anatomy; 6. Females of childbearing age have positive blood pregnancy tests, and lactating patients; 7. Patients with uncontrolled diabetes and hypertension; 8. Those with stones in the calyceal diverticulum; 9. Other circumstances that the investigator believes may hinder the evaluation of the results or pose a risk to the health of the subjects.

Design outcomes

Primary

MeasureTime frame
Effectiveness evaluation;

Secondary

MeasureTime frame
Safety evaluation;

Countries

China

Contacts

Public ContactFu Qiang

Shanghai Sixth People's Hospital

jamesqfu@aliyun.com+86 13501834727

Outcome results

None listed

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