Ureteral StrictureNCT04129645
Safety and Efficacy of URS Stents in the Treatment of Ureteral Stricture
An observational study of Ureteral Stricture, run by Peking University People's Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ureteral Stricture
- What is being tested?
- URS
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from ureteral obstruction that require treatment.
Who may be able to join
- 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
Who cannot join
- Combine with hypertonic neurogenic bladder (except for patients with long-term indwelling catheter)
- Colon resection surgery patients -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peiking university people's hospital
Beijing, Beijing Municipality, 100044
Mingrui p Wang, 15725555614@163.com
About this study
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
A prospective observational study aimed to assess the efficacy and safety of Allium ureteral stent long-term indwelling in the treatment of ureteral stricture.
- Conditions
- Ureteral Stricture
- Being tested
- URS
- Keywords
- Ureteral, ureteral stent, ureteral stricture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Patency rate
Number of patients evaluated with hydronephrosis
Measured: Up to 36 months
Indwelling time
Number of months of the implant in the ureter
Measured: Up to 36 months
Device related serious adverse events
Number of device related serious adverse events
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start1 Jan 2020
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral StrictureStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huhao, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129645
- Sponsor's protocol ID
- URO-01
- Status last verified
- Jun 2022
- First submitted
- 15 Oct 2019
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04129645
- Acronym / sponsor ID
- URO-01
- Conditions
- Ureteral Stricture
- Keywords
- Ureteral, ureteral stent, ureteral stricture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 17 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective observational study aimed to assess the efficacy and safety of Allium ureteral stent long-term indwelling in the treatment of ureteral stricture.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from ureteral obstruction that require treatment.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Combine with hypertonic neurogenic bladder (except for patients with long-term indwelling catheter)
- Colon resection surgery patients -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| URSURS 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. | Device | – |
Primary outcome
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
Device related serious adverse events
Time frame: Up to 36 months
Number of device related serious adverse events
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ureteral Stricture, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weihong Feng (86-10-68946338 ext. 801, fengwhr@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patency rate (time frame: Up to 36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2022.