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Clinical Trials/NCT04129645
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

Peking University People's Hospital1 site in 1 country500 target enrollmentJanuary 1, 2020

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2020
End Date
July 1, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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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