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The real-world observation of single used digital ureterscopy

The real-world observation of single used digital ureterscopy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200059306
Enrollment
Unknown
Registered
2022-04-28
Start date
2022-04-28
Completion date
Unknown
Last updated
2024-02-26

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

Conditions

Urinary calculi

Interventions

Observation Group:Operation

Sponsors

PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. According to the guidelines for diagnosis and treatment of diseases in Chinese urology and andrology (2019 Edition), ureteral stones that meet the indications of ureteroscopic lithotripsy (such as middle and lower ureteral stones, upper ureteral stones after ESWL treatment failure, stone street after ESWL, X-ray negative ureteral stones, incarcerated stones with long residence time, etc.), Or renal calculi that meet the indications of ureteroscopic lithotripsy (such as X-ray negative renal calculi with difficult ESWL positioning, residual lower renal calyceal calculi after ESWL, incarcerated lower renal calyceal calculi with poor ESWL treatment effect, extreme obesity, severe spinal deformity, ectopic kidney complicated with renal calculi, PNL difficult to establish channel, hard stones that are not conducive to ESWL treatment, stones in the renal calyceal diverticulum, and < 2cm renal calculi complicated with pararenal cyst, etc.) And ureteral calculi (such as upper ureteral calculi, patients with ureteral distortion and hard endoscopy unable to reach the stone site, extremely obese patients, patients with mild bleeding tendency or unable to stop anticoagulant drugs); 2. The length and diameter of stones < 6.0 cm; 3. Age 18-70 years old, regardless of gender; 4. F8/9.8 patients with ureteroscopy unable to successfully reach the stone position for lithotripsy or failure to insert F11/13 ureteroscopy sheath.

Exclusion criteria

Exclusion criteria: 1. Uncontrollable systemic hemorrhagic diseases; 2. Severe cardiopulmonary insufficiency, unable to tolerate surgery; 3. Uncontrolled urinary tract infection; 4. Severe urethral stricture, intracavitary surgery can not solve; 5. Severe hip deformity and difficult lithotomy position; 6. The applicable population and contraindications are derived from the 2016 guidelines for the diagnosis and treatment of urolithiasis.

Design outcomes

Primary

MeasureTime frame
Success rate of disposable soft mirror entering renal pelvis;Operation time;Operation success rate;Patient satisfaction;Performance of medical devices;Calculation of stone removal rate;

Countries

China

Contacts

Public ContactMai Haixing

PLA General Hospital

574719550@qq.com+86 13466366606

Outcome results

None listed

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