Ureter StrictureNCT04250090
Post-Marketing Follow-Up of Long-term Type Ureteral Stent Set
An observational study of Ureter Stricture and Hydronephrosis, run by En Chu Kong Hospital at 1 site in Taiwan.
Trial summary
Ureteral stents have been widely used in many urological operations. Although there are several reports regarding the effectiveness of long-term ureteral stents for malignancy ureteral obstruction, ureteral stricture and urolithiasis, the experience is limited about the long-term ureteral stents made by Taiwan. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Ureter Stricture, Hydronephrosis
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Jul 2019to 31 Oct 2022
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The most recent patients who actually used the " Bioteq" Ureteral Stent Set (Long-Term Type) are included, and a non-grouping method is adopted
Who may be able to join
- Patients who used " Bioteq" Ureteral Stent Set (Long-Term Type) in their treatments.
- Patients with complete basic parameters.
Who cannot join
- Patients with any of the following conditions are excluded from this clinical study:
- Patients with incomplete basic parameters.
- The minorities, children and special populations
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
En Chu Kong Hospital
New Taipei City, Sanxia Dist., 23702
Chung Cheng Wang, Ph. D, 886-226723456 ext. 6620, ericwcc@ms27.hinet.net
About this study
Ureteral stents have been widely used in many urological operations. Although there are several reports regarding the effectiveness of long-term ureteral stents for malignancy ureteral obstruction, ureteral stricture and urolithiasis, the experience is limited about the long-term ureteral stents made by Taiwan. The investigators have to propose the 5-year post-market survey report. Though this observation study, The investigators can further understand the clinical safety and effectiveness of placing ureteral stents
Read the detailed description
Ureteral stents have been widely used in many urological operations. The main purposes of placing ureteral stents include improvement of ureteral obstruction, protecting renal function and drainage of infection. Although there are several reports regarding the effectiveness of long-term ureteral stents for malignancy ureteral obstruction, ureteral stricture and urolithiasis, the experience is limited about the long-term ureteral stents made by Taiwan. Thus, The investigators will conduct this post-marketing survey to observe and investigate the changes of ureteral stents, e.g. hydronephrosis, infection and stone formation. Now this product has been approved by European Medical Device Administration. The investigators have to propose the 5-year post-market survey report. Though this observation study, The investigators can further understand the clinical safety and effectiveness of placing ureteral stents
- Conditions
- Ureter Stricture, Hydronephrosis
- Keywords
- Ureter Stricture, Hydronephrosis
- Medical subject headings
- Hydronephrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Long-term type ureteral stent set | Patients with Long-term type ureteral stent set due to ureteral stricture. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hydronephrosis
no hydronephrosis, mild hydronephrosis, moderate hydronephrosis, severe hydronephrosis
Measured: 5 years
Renal function
serum BUN level
Measured: 5 years
Renal function
serum Creatine level
Measured: 5 years
Days of stent placement
Mean days of stent placement
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start9 Jul 2019
- Primary completion30 Jul 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Ureter StrictureStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 20 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. Ph. D, Principal investigator, Deputy Superintendent of Department of Education and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04250090
- Sponsor's protocol ID
- ECKIRB1050505
- Status last verified
- Feb 2020
- First submitted
- 17 Jan 2020
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liatsikos EN, Kagadis GC, Barbalias GA, Siablis D. Ureteral metal stents: a tale or a tool? J Endourol. 2005 Oct;19(8):934-9. doi: 10.1089/end.2005.19.934.
PubMed 16253054Zeljko M, Markovic B, Mladenovic A, Mijailovic M, Lukic S. Balloon dilatation and insertion of temporary coated stents using a retrograde approach in patients with irreversible strictures of the distal ureter. Jpn J Radiol. 2010 Nov;28(9):695-9. doi: 10.1007/s11604-010-0485-2. Epub 2010 Nov 27.
PubMed 21113756Bach T, Geavlete B, Herrmann TW, Gross AJ. Retrograde blind endoureterotomy for subtotal ureteral strictures: a new technique. J Endourol. 2008 Nov;22(11):2565-70. doi: 10.1089/end.2008.0173.
PubMed 19046096Aytekin C, Boyvat F, Harman A, Ozyer U, Colak T, Haberal M. Percutaneous therapy of ureteral obstructions and leak after renal transplantation: long-term results. Cardiovasc Intervent Radiol. 2007 Nov-Dec;30(6):1178-84. doi: 10.1007/s00270-007-9031-8. Epub 2007 May 17.
PubMed 17508243Kim BM, Park SI. Placement of double-J ureteric stent using the pull-through technique in patients with tight ureteric stenosis. Abdom Imaging. 2008 Mar-Apr;33(2):237-40. doi: 10.1007/s00261-007-9233-1.
PubMed 17440767Juaneda B, Alcaraz A, Bujons A, Guirado L, Diaz JM, Marti J, de la Torre P, Sabate S, Villavicencio H. Endourological management is better in early-onset ureteral stenosis in kidney transplantation. Transplant Proc. 2005 Nov;37(9):3825-7. doi: 10.1016/j.transproceed.2005.09.199.
PubMed 16386552Egilmez T, Guvel S, Kilinc F, Yaycioglu O, Ozkardes H. Management of complete ureteral obstructions with a transluminal puncture technique. Int Braz J Urol. 2005 May-Jun;31(3):264-8. doi: 10.1590/s1677-55382005000300013.
PubMed 15992432Uthappa MC, Cowan NC. Retrograde or antegrade double-pigtail stent placement for malignant ureteric obstruction? Clin Radiol. 2005 May;60(5):608-12. doi: 10.1016/j.crad.2004.11.014.
PubMed 15851050Unsal A, Cimentepe E, Balbay MD. Routine ureteral dilatation is not necessary for ureteroscopy. Int Urol Nephrol. 2004;36(4):503-6. doi: 10.1007/s11255-004-0860-y.
PubMed 15787325Mattei A, Danuser H. [Stents in urology]. Ther Umsch. 2003 Apr;60(4):233-7. doi: 10.1024/0040-5930.60.4.233. German.
PubMed 12731434Barbalias GA, Liatsikos EN, Kalogeropoulou C, Karnabatidis D, Zabakis P, Athanasopoulos A, Perimenis P, Siablis D. Externally coated ureteral metallic stents: an unfavorable clinical experience. Eur Urol. 2002 Sep;42(3):276-80. doi: 10.1016/s0302-2838(02)00281-6.
PubMed 12234513Hibi H, Kato K, Mitsui K, Taki T, Yamada Y, Honda N, Fukatsu H. Endoscopic ureteral incision using the holmium:YAG laser. Int J Urol. 2001 Dec;8(12):657-61. doi: 10.1046/j.1442-2042.2001.00393.x.
PubMed 11851764Micali S, De Carli P, Miano R, O'Sullivan D, Lamanna L, Micali F. Double-J ureteral stents: an alternative to external urinary stents in orthotopic bladder substitution. Eur Urol. 2001 May;39(5):575-9. doi: 10.1159/000052506.
PubMed 11464040Lin DW, Bush WH, Mayo ME. Endourological treatment of ureteroenteric strictures: efficacy of Acucise endoureterotomy. J Urol. 1999 Sep;162(3 Pt 1):696-8. doi: 10.1097/00005392-199909010-00017.
PubMed 10458345Puppo P, Ricciotti G, Bozzo W, Introini C. Primary endoscopic treatment of ureteric calculi. A review of 378 cases. Eur Urol. 1999;36(1):48-52. doi: 10.1159/000019926.
PubMed 10364655
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Follow-Up of Long-term Type Ureteral Stent Set
- ClinicalTrials.gov ID
- NCT04250090
- Acronym / sponsor ID
- ECKIRB1050505
- Conditions
- Ureter Stricture, Hydronephrosis
- Keywords
- Ureter Stricture, Hydronephrosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- En Chu Kong HospitalUniversity, hospital or other
- Study start
- 9 Jul 2019 (actual)
- Primary completion
- 30 Jul 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 31 Jan 2020 (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.
Ureteral stents have been widely used in many urological operations. Although there are several reports regarding the effectiveness of long-term ureteral stents for malignancy ureteral obstruction, ureteral stricture and urolithiasis, the experience is limited about the long-term ureteral stents made by Taiwan. The investigators have to propose the 5-year post-market survey report. Though this observation study, The investigators can further understand the clinical safety and effectiveness of placing ureteral stents
Detailed description
Ureteral stents have been widely used in many urological operations. The main purposes of placing ureteral stents include improvement of ureteral obstruction, protecting renal function and drainage of infection. Although there are several reports regarding the effectiveness of long-term ureteral stents for malignancy ureteral obstruction, ureteral stricture and urolithiasis, the experience is limited about the long-term ureteral stents made by Taiwan. Thus, The investigators will conduct this post-marketing survey to observe and investigate the changes of ureteral stents, e.g. hydronephrosis, infection and stone formation. Now this product has been approved by European Medical Device Administration. The investigators have to propose the 5-year post-market survey report. Though this observation study, The investigators can further understand the clinical safety and effectiveness of placing ureteral stents
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Long-term type ureteral stent set | – | –Patients with Long-term type ureteral stent set due to ureteral stricture. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The most recent patients who actually used the " Bioteq" Ureteral Stent Set (Long-Term Type) are included, and a non-grouping method is adopted
Key inclusion criteria (2 listed)
- Patients who used " Bioteq" Ureteral Stent Set (Long-Term Type) in their treatments.
- Patients with complete basic parameters.
Key exclusion criteria (3 listed)
- Patients with any of the following conditions are excluded from this clinical study:
- Patients with incomplete basic parameters.
- The minorities, children and special populations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hydronephrosis
Time frame: 5 years
no hydronephrosis, mild hydronephrosis, moderate hydronephrosis, severe hydronephrosis
Renal function
Time frame: 5 years
serum BUN level
Renal function
Time frame: 5 years
serum Creatine level
Days of stent placement
Time frame: 5 years
Mean days of stent placement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Results publication: PubMed 16253054Liatsikos EN, Kagadis GC, Barbalias GA, Siablis D. Ureteral metal stents: a tale or a tool? J Endourol. 2005 Oct;19(8):934-9. doi: 10.1089/end.2005.19.934.
- Results publication: PubMed 21113756Zeljko M, Markovic B, Mladenovic A, Mijailovic M, Lukic S. Balloon dilatation and insertion of temporary coated stents using a retrograde approach in patients with irreversible strictures of the distal ureter. Jpn J Radiol. 2010 Nov;28(9):695-9. doi: 10.1007/s11604-010-0485-2. Epub 2010 Nov 27.
- Results publication: PubMed 19046096Bach T, Geavlete B, Herrmann TW, Gross AJ. Retrograde blind endoureterotomy for subtotal ureteral strictures: a new technique. J Endourol. 2008 Nov;22(11):2565-70. doi: 10.1089/end.2008.0173.
- Results publication: PubMed 17508243Aytekin C, Boyvat F, Harman A, Ozyer U, Colak T, Haberal M. Percutaneous therapy of ureteral obstructions and leak after renal transplantation: long-term results. Cardiovasc Intervent Radiol. 2007 Nov-Dec;30(6):1178-84. doi: 10.1007/s00270-007-9031-8. Epub 2007 May 17.
- Results publication: PubMed 17440767Kim BM, Park SI. Placement of double-J ureteric stent using the pull-through technique in patients with tight ureteric stenosis. Abdom Imaging. 2008 Mar-Apr;33(2):237-40. doi: 10.1007/s00261-007-9233-1.
- Results publication: PubMed 16386552Juaneda B, Alcaraz A, Bujons A, Guirado L, Diaz JM, Marti J, de la Torre P, Sabate S, Villavicencio H. Endourological management is better in early-onset ureteral stenosis in kidney transplantation. Transplant Proc. 2005 Nov;37(9):3825-7. doi: 10.1016/j.transproceed.2005.09.199.
- Results publication: PubMed 15992432Egilmez T, Guvel S, Kilinc F, Yaycioglu O, Ozkardes H. Management of complete ureteral obstructions with a transluminal puncture technique. Int Braz J Urol. 2005 May-Jun;31(3):264-8. doi: 10.1590/s1677-55382005000300013.
- Results publication: PubMed 15851050Uthappa MC, Cowan NC. Retrograde or antegrade double-pigtail stent placement for malignant ureteric obstruction? Clin Radiol. 2005 May;60(5):608-12. doi: 10.1016/j.crad.2004.11.014.
- Results publication: PubMed 15787325Unsal A, Cimentepe E, Balbay MD. Routine ureteral dilatation is not necessary for ureteroscopy. Int Urol Nephrol. 2004;36(4):503-6. doi: 10.1007/s11255-004-0860-y.
- Results publication: PubMed 12731434Mattei A, Danuser H. [Stents in urology]. Ther Umsch. 2003 Apr;60(4):233-7. doi: 10.1024/0040-5930.60.4.233. German.
- Results publication: PubMed 12234513Barbalias GA, Liatsikos EN, Kalogeropoulou C, Karnabatidis D, Zabakis P, Athanasopoulos A, Perimenis P, Siablis D. Externally coated ureteral metallic stents: an unfavorable clinical experience. Eur Urol. 2002 Sep;42(3):276-80. doi: 10.1016/s0302-2838(02)00281-6.
- Results publication: PubMed 11851764Hibi H, Kato K, Mitsui K, Taki T, Yamada Y, Honda N, Fukatsu H. Endoscopic ureteral incision using the holmium:YAG laser. Int J Urol. 2001 Dec;8(12):657-61. doi: 10.1046/j.1442-2042.2001.00393.x.
- 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.
Chung Cheng Wang, MD. Ph. D principal investigator
Deputy Superintendent of Department of Education and Research
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 Ureter Stricture 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 2 inclusion and 3 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 11 Feb 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chung Cheng Wang, MD. Ph. D (886-226723456 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?
Hydronephrosis (time frame: 5 years). The study lists 4 primary outcomes in all. 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 NCT04250090, which also lists 29 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 11 Feb 2020.