Ureteral StenosisAlliumNCT05455307
Efficacy and Safety of Allium Ureteral Stent for Treating Refractory Ureteral Stricture
A study testing Allium ureteral stent in people with Ureteral Stenosis and Hydronephrosis, run by En Chu Kong Hospital at 1 site in Taiwan.
Trial summary
To conduct a prospective, multi-center study to observe the long-term efficacy and safety of self expanding ureteral stent for treating participants with refractory ureteral stricture. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ureteral Stenosis, Hydronephrosis, Ureteral Stent Occlusion
- What is being tested?
- Allium ureteral stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Jul 2022to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- refractory ureteral stricture after at least two times of ureteral dilation
Who cannot join
- poor cardiovascular function for anesthesia unwilling to accept the long-term placement of ureteral stent uncontrolled urinary tract infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
En Chu Kong Hospital
New Taipei City, 23702
Chung Cheng Wang, MD PhD, 886-26723456 ext. 6620, ericwcc@ms27.hinet.net
Hsin-Yi Lin, BS, 886-26723456 ext. 6621, hhan309@gmail.com
About this study
Official title: Efficacy and Safety of Self-expanding Ureteral Stent for Treating Refractory Ureteral Stricture: Results of a Multicenter Experience
To conduct a prospective, multi-center study to observe the long-term efficacy and safety of self expanding ureteral stent for treating participants with refractory ureteral stricture.
Read the detailed description
The aim of the study is to conduct a prospective, multi-center study to observe the long-term efficacy and safety of self expanding ureteral stent for treating participants with refractory ureteral stricture.
About 200 participants with refractory ureteral stricture will be enrolled in four hospitals. After the allium ureteral stents are placed, renal function, renal echo, images and associated complications will be recorded.
- Conditions
- Ureteral Stenosis, Hydronephrosis, Ureteral Stent Occlusion
- Being tested
- Allium ureteral stent
- Keywords
- ureteral stone, ureteral stricture, hydronephrosis
- Medical subject headings
- Hydronephrosis, Ureterolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allium ureteral stentDevice
observe the effficacy and safety of long-term self expanding ureteral stents for treating refractory ureteral stricture
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | single arm without placebo control Receives: Device: Allium ureteral stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal function test
serum creatinine (mg/dL)
Measured: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months and 60 months
Secondary outcomes (2)
Complications
device associated complications (e.g. urinary tract infection, stone formation, hematuria, stent migration)
Measured: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months and 60 months
Renal structure
Renal echo (e.g. no hydronephrosis, mild hydronephrosis, moderate hydronephrosis, orsevere hydronephrosis)
Measured: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months and 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start30 Jul 2022 (estimated)
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ureteral StenosisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single group without control
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- En Chu Kong Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ChungChengWang, En Chu Kong Hospital
- Investigators
- Chung Cheng Wang, MD PhD, Principal investigator, En Chu Kong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455307
- Sponsor's protocol ID
- eck20200608
- Acronym
- Allium
- Status last verified
- Jul 2022
- First submitted
- 8 Jun 2022
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Other researchers can e-mail to us for data sharing
Publications
Avitan O, Bahouth Z, Shprits S, Gorenberg M, Halachmi S. Allium Ureteral Stent as a Treatment for Ureteral Stricture: Results and Concerns. Urol Int. 2022;106(5):482-486. doi: 10.1159/000522174. Epub 2022 Mar 1.
PubMed 35231922Sampogna G, Grasso A, Montanari E. Expandable metallic ureteral stent: indications and results. Minerva Urol Nefrol. 2018 Jun;70(3):275-285. doi: 10.23736/S0393-2249.18.03035-7. Epub 2018 Mar 28.
PubMed 29595037
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Self-expanding Ureteral Stent for Treating Refractory Ureteral Stricture: Results of a Multicenter Experience
- ClinicalTrials.gov ID
- NCT05455307
- Acronym / sponsor ID
- Allium / eck20200608
- Conditions
- Ureteral Stenosis, Hydronephrosis, Ureteral Stent Occlusion
- Keywords
- ureteral stone, ureteral stricture, hydronephrosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- En Chu Kong HospitalUniversity, hospital or other
- Study start
- 30 Jul 2022 (estimated)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 13 Jul 2022 (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.
To conduct a prospective, multi-center study to observe the long-term efficacy and safety of self expanding ureteral stent for treating participants with refractory ureteral stricture.
Detailed description
The aim of the study is to conduct a prospective, multi-center study to observe the long-term efficacy and safety of self expanding ureteral stent for treating participants with refractory ureteral stricture.
About 200 participants with refractory ureteral stricture will be enrolled in four hospitals. After the allium ureteral stents are placed, renal function, renal echo, images and associated complications will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single group without control
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Device: Allium ureteral stentsingle arm without placebo control |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- refractory ureteral stricture after at least two times of ureteral dilation
Key exclusion criteria (1 listed)
- poor cardiovascular function for anesthesia unwilling to accept the long-term placement of ureteral stent uncontrolled urinary tract infection
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 |
|---|---|---|
| Allium ureteral stentobserve the effficacy and safety of long-term self expanding ureteral stents for treating refractory ureteral stricture | Device | single arm |
Primary outcome
Renal function test
Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months and 60 months
serum creatinine (mg/dL)
2 secondary outcomes
Complications
Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months and 60 months
Renal structure
Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months and 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- Results publication: PubMed 35231922Avitan O, Bahouth Z, Shprits S, Gorenberg M, Halachmi S. Allium Ureteral Stent as a Treatment for Ureteral Stricture: Results and Concerns. Urol Int. 2022;106(5):482-486. doi: 10.1159/000522174. Epub 2022 Mar 1.
- Results publication: PubMed 29595037Sampogna G, Grasso A, Montanari E. Expandable metallic ureteral stent: indications and results. Minerva Urol Nefrol. 2018 Jun;70(3):275-285. doi: 10.23736/S0393-2249.18.03035-7. Epub 2018 Mar 28.
- Individual participant dataSharing planned: No. Other researchers can e-mail to us for data sharing
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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.
Chung Cheng Wang, MD PhD principal investigator
En Chu Kong Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allium ureteral stent in people with Ureteral Stenosis and Hydronephrosis, run by En Chu Kong Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 13 Jul 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chung Cheng Wang, MD PhD (886-26723456 ext. 6620, ericwcc@ms27.hinet.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal function test (time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months and 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05455307, which also lists 2 linked publications.
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 13 Jul 2022.