NCT04129645

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

June 16, 2022

Status Verified

June 1, 2022

Enrollment Period

3 years

First QC Date

October 15, 2019

Last Update Submit

June 13, 2022

Conditions

Ureteral Stricture

Keywords

Ureteralureteral stentureteral stricture

Outcome Measures

Primary Outcomes (3)

  • Patency rate

    Number of patients evaluated with hydronephrosis

    Up to 36 months

  • Indwelling time

    Number of months of the implant in the ureter

    Up to 36 months

  • Device related serious adverse events

    Number of device related serious adverse events

    Up to 36 months

Interventions

URSDEVICE

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.

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients suffering from ureteral obstruction that require treatment.

You may qualify if:

  • 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

You may not qualify if:

  • Combine with hypertonic neurogenic bladder (except for patients with long-term indwelling catheter)
  • Colon resection surgery patients -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peiking university people's hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Central Study Contacts

Weihong Feng

CONTACT

86-10-68946338fengwhr@139.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

October 15, 2019

First Posted

October 17, 2019

Study Start

January 1, 2020

Primary Completion

January 1, 2023

Study Completion

July 1, 2023

Last Updated

June 16, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)