ClinicalTrials.gg
Status unknownNCT04250090Updated Feb 11, 2020

Post-Marketing Follow-Up of Long-term Type Ureteral Stent Set

An observational study in Ureter Stricture and Hydronephrosis, sponsored by En Chu Kong Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2020-02-11.

Sponsored by En Chu Kong Hospital · Observational

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
20
Ages
20 Years and older
Sex
All
01

Study 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. 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

02

Conditions studied

  • Ureter Stricture
  • Hydronephrosis

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Keywords

  • Ureter Stricture
  • Hydronephrosis
03

In context

Hydronephrosis

55 studies on the registry are indexed under Hydronephrosis; 9 are open to participants now.

This study's planned enrollment of 20 is below the median of 78 across 25 observational studies indexed under Hydronephrosis.

Browse Hydronephrosis studies →

Lead sponsor

En Chu Kong Hospital is the lead sponsor of 10 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients who used " Bioteq" Ureteral Stent Set (Long-Term Type) in their treatments.
  2. Patients with complete basic parameters.

Exclusion criteria

Exclusion Criteria:

  1. Patients with any of the following conditions are excluded from this clinical study:

    Patients with incomplete basic parameters.

  2. The minorities, children and special populations
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • Long-term type ureteral stent set

    Patients with Long-term type ureteral stent set due to ureteral stricture.

06

What researchers measure

Primary outcomes

  1. Hydronephrosis

    no hydronephrosis, mild hydronephrosis, moderate hydronephrosis, severe hydronephrosis

    Time frame: 5 years

  2. Renal function

    serum BUN level

    Time frame: 5 years

  3. Renal function

    serum Creatine level

    Time frame: 5 years

  4. Days of stent placement

    Mean days of stent placement

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
  • En Chu Kong Hospital
    New Taipei City, Sanxia Dist. 23702, Taiwan
    Recruiting
08

References and documents

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 16253054 ↗
  • Zeljko 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 21113756 ↗
  • Bach 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 19046096 ↗
  • Aytekin 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 17508243 ↗
  • Kim 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 17440767 ↗
  • Juaneda 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 16386552 ↗
  • Egilmez 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 15992432 ↗
  • Uthappa 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 15851050 ↗
  • Unsal 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 15787325 ↗
  • Mattei A, Danuser H. [Stents in urology]. Ther Umsch. 2003 Apr;60(4):233-7. doi: 10.1024/0040-5930.60.4.233. German. PubMed 12731434 ↗
  • Barbalias 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 12234513 ↗
  • Hibi 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 11851764 ↗
  • Micali 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 11464040 ↗
  • Lin 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 10458345 ↗
  • Puppo 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 ↗
  • Ravery V, de la Taille A, Hoffmann P, Moulinier F, Hermieu JF, Delmas V, Boccon-Gibod L. Balloon catheter dilatation in the treatment of ureteral and ureteroenteric stricture. J Endourol. 1998 Aug;12(4):335-40. doi: 10.1089/end.1998.12.335. PubMed 9726399 ↗
  • Zimskind PD, Fetter TR, Wilkerson JL. Clinical use of long-term indwelling silicone rubber ureteral splints inserted cystoscopically. J Urol. 1967 May;97(5):840-4. doi: 10.1016/S0022-5347(17)63130-6. No abstract available. PubMed 6025928 ↗
  • Richter S, Ringel A, Shalev M, Nissenkorn I. The indwelling ureteric stent: a 'friendly' procedure with unfriendly high morbidity. BJU Int. 2000 Mar;85(4):408-11. doi: 10.1046/j.1464-410x.1998.00543.x-i1. PubMed 10691815 ↗
  • Pocock RD, Stower MJ, Ferro MA, Smith PJ, Gingell JC. Double J stents. A review of 100 patients. Br J Urol. 1986 Dec;58(6):629-33. doi: 10.1111/j.1464-410x.1986.tb05900.x. PubMed 3801820 ↗
  • Saltzman B. Ureteral stents. Indications, variations, and complications. Urol Clin North Am. 1988 Aug;15(3):481-91. PubMed 3043868 ↗
  • Ahallal Y, Khallouk A, El Fassi MJ, Farih MH. Risk factor analysis and management of ureteral double-j stent complications. Rev Urol. 2010 Spring;12(2-3):e147-51. PubMed 20811552 ↗
  • Lam JS, Gupta M. Tips and tricks for the management of retained ureteral stents. J Endourol. 2002 Dec;16(10):733-41. doi: 10.1089/08927790260472881. PubMed 12542876 ↗
  • Borboroglu PG, Kane CJ. Current management of severely encrusted ureteral stents with a large associated stone burden. J Urol. 2000 Sep;164(3 Pt 1):648-50. doi: 10.1097/00005392-200009010-00007. PubMed 10953117 ↗
  • Mohan-Pillai K, Keeley FX Jr, Moussa SA, Smith G, Tolley DA. Endourological management of severely encrusted ureteral stents. J Endourol. 1999 Jun;13(5):377-9. doi: 10.1089/end.1999.13.377. PubMed 10446801 ↗
  • Schulze KA, Wettlaufer JN, Oldani G. Encrustation and stone formation: complication of indwelling ureteral stents. Urology. 1985 Jun;25(6):616-9. doi: 10.1016/0090-4295(85)90293-6. PubMed 4012953 ↗
  • el-Faqih SR, Shamsuddin AB, Chakrabarti A, Atassi R, Kardar AH, Osman MK, Husain I. Polyurethane internal ureteral stents in treatment of stone patients: morbidity related to indwelling times. J Urol. 1991 Dec;146(6):1487-91. doi: 10.1016/s0022-5347(17)38146-6. PubMed 1942324 ↗
  • Somers WJ. Management of forgotten or retained indwelling ureteral stents. Urology. 1996 Mar;47(3):431-5. doi: 10.1016/S0090-4295(99)80468-3. PubMed 8633417 ↗
  • Singh I, Gupta NP, Hemal AK, Aron M, Seth A, Dogra PN. Severely encrusted polyurethane ureteral stents: management and analysis of potential risk factors. Urology. 2001 Oct;58(4):526-31. doi: 10.1016/s0090-4295(01)01317-6. PubMed 11597531 ↗
  • Kilciler M, Erdemir F, Bedir S, Coban H, Erten K, Guven O, Topac H. Spontaneous ureteral stent fragmentation: a case report and review of the literature. Kaohsiung J Med Sci. 2006 Jul;22(7):363-6. doi: 10.1016/S1607-551X(09)70324-9. PubMed 16849106 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2019 (actual). Primary completion is estimated for Jul 2022, 36 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 17, 2020
First posted
Jan 31, 2020
StartActual
Jul 9, 2019
Primary completionEst.
Jul 30, 2022
CompletionEst.
Oct 31, 2022
Last update
Feb 11, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04250090
Lead sponsor
En Chu Kong Hospital
Responsible party
ChungChengWang (Chief of urology, En Chu Kong Hospital) — Principal investigator
First posted
Jan 31, 2020
Start date
Jul 9, 2019
Primary completion
Jul 30, 2022 (estimated)
Completion
Oct 31, 2022 (estimated)
Last update
Feb 11, 2020

Study contacts

Chung Cheng Wang, MD. Ph. D
Contact
ericwcc@ms27.hinet.net
886-226723456 ext. 6620
Chung Cheng Wang, MD. Ph. D
principal investigator · Deputy Superintendent of Department of Education and Research

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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