NCT04129645
Unknown
Not Applicable
Prospective Observational Study for Assessment of the Efficacy and Safety of Allium Ureteral Stent Long-term Indwelling in the Treatment of Ureteral Stricture
ConditionsUreteral Stricture
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ureteral Stricture
- Sponsor
- Peking University People's Hospital
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Device related serious adverse events
- Last Updated
- 3 years ago
Overview
Brief Summary
A prospective observational study aimed to assess the efficacy and safety of Allium ureteral stent long-term indwelling in the treatment of ureteral stricture.
Investigators
Huhao
Primary Investigator
Peking University People's Hospital
Eligibility Criteria
Inclusion Criteria
- •Benign diseases: UPJ, ischemic injury caused by surgical separation, endoscopic surgery injury, heat injury by laser lithotripsy, infection (chronic inflammation, tuberculosis), peri-ureteral fibrosis caused by endometriosis, ureteral anastomotic stenosis after renal transplantation, ureteral fistula, multiple polyps;
- •Malignant diseases: ureteral anastomotic stricture after urinary diversion, stricture caused by compression of abdominal and/or pelvic tumors, stricture caused by urinary tract tumors, stricture caused by radiotherapy for colon or cervical cancer, ureteral fistula
Exclusion Criteria
- •Combine with hypertonic neurogenic bladder (except for patients with long-term indwelling catheter)
- •Colon resection surgery patients -
Outcomes
Primary Outcomes
Device related serious adverse events
Time Frame: Up to 36 months
Number of device related serious adverse events
Patency rate
Time Frame: Up to 36 months
Number of patients evaluated with hydronephrosis
Indwelling time
Time Frame: Up to 36 months
Number of months of the implant in the ureter
Study Sites (1)
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