Safety and Efficacy of URS Stents in the Treatment of Ureteral Stricture

Ureteral Stricture Clinical Trial

Official title:

Prospective Observational Study for Assessment of the Efficacy and Safety of Allium Ureteral Stent Long-term Indwelling in the Treatment of Ureteral Stricture

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04129645
• Other study ID #: URO-01
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: July 1, 2023

Study information

• Verified date: June 2022
• Source: Peking University People's Hospital
• Contact: Weihong Feng
• Phone: 86-10-68946338
• Email: fengwhr[@]139.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. 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;

2. 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:

1. Combine with hypertonic neurogenic bladder (except for patients with long-term indwelling catheter)

2. Colon resection surgery patients -

Related Conditions & MeSH terms

• Constriction, Pathologic
• Ureteral Stricture

Intervention

Device:
• URS
URS is a permanent ureteral stent made of nitinol and covered by a polymer, that is indicated to open strictures in the ureter. Study patients who has strictures in the ureter, will be implanted with the URS for long term opening of the stricture.

Locations

Country	Name	City	State
China	Peiking university people's hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patency rate	Number of patients evaluated with hydronephrosis	Up to 36 months
Primary	Indwelling time	Number of months of the implant in the ureter	Up to 36 months
Primary	Device related serious adverse events	Number of device related serious adverse events	Up to 36 months