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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04129645

Enrollment

500

Registered

2019-10-17

Start date

2020-01-01

Completion date

2023-07-01

Last updated

2022-06-16

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

Conditions

Ureteral Stricture

Keywords

Ureteral, ureteral stent, ureteral stricture

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.

Interventions

DEVICEURS

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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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 -

Design outcomes

Primary

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

Countries

China

Contacts

Primary ContactWeihong Feng

fengwhr@139.com86-10-68946338

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026