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

NCT ID: NCT04250090

Last Updated: 2020-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-09

Study Completion Date

2022-10-31

Brief Summary

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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

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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

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Ureter Stricture Hydronephrosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Long-term type ureteral stent set

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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En Chu Kong Hospital

OTHER

Sponsor Role lead

Responsible Party

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ChungChengWang

Chief of urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chung Cheng Wang, MD. Ph. D

Role: PRINCIPAL_INVESTIGATOR

Deputy Superintendent of Department of Education and Research

Locations

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En Chu Kong Hospital

New Taipei City, Sanxia Dist., Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chung Cheng Wang, MD. Ph. D

Role: CONTACT

886-226723456 ext. 6620

Facility Contacts

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Chung Cheng Wang, Ph. D

Role: primary

886-226723456 ext. 6620

References

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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.

Reference Type RESULT
PMID: 16253054 (View on PubMed)

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.

Reference Type RESULT
PMID: 21113756 (View on PubMed)

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.

Reference Type RESULT
PMID: 19046096 (View on PubMed)

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.

Reference Type RESULT
PMID: 17508243 (View on PubMed)

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.

Reference Type RESULT
PMID: 17440767 (View on PubMed)

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.

Reference Type RESULT
PMID: 16386552 (View on PubMed)

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.

Reference Type RESULT
PMID: 15992432 (View on PubMed)

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.

Reference Type RESULT
PMID: 15851050 (View on PubMed)

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.

Reference Type RESULT
PMID: 15787325 (View on PubMed)

Mattei A, Danuser H. [Stents in urology]. Ther Umsch. 2003 Apr;60(4):233-7. doi: 10.1024/0040-5930.60.4.233. German.

Reference Type RESULT
PMID: 12731434 (View on PubMed)

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.

Reference Type RESULT
PMID: 12234513 (View on PubMed)

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.

Reference Type RESULT
PMID: 11851764 (View on PubMed)

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.

Reference Type RESULT
PMID: 11464040 (View on PubMed)

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.

Reference Type RESULT
PMID: 10458345 (View on PubMed)

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.

Reference Type RESULT
PMID: 10364655 (View on PubMed)

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.

Reference Type RESULT
PMID: 9726399 (View on PubMed)

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.

Reference Type RESULT
PMID: 6025928 (View on PubMed)

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.

Reference Type RESULT
PMID: 10691815 (View on PubMed)

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.

Reference Type RESULT
PMID: 3801820 (View on PubMed)

Saltzman B. Ureteral stents. Indications, variations, and complications. Urol Clin North Am. 1988 Aug;15(3):481-91.

Reference Type RESULT
PMID: 3043868 (View on PubMed)

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.

Reference Type RESULT
PMID: 20811552 (View on PubMed)

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.

Reference Type RESULT
PMID: 12542876 (View on PubMed)

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.

Reference Type RESULT
PMID: 10953117 (View on PubMed)

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.

Reference Type RESULT
PMID: 10446801 (View on PubMed)

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.

Reference Type RESULT
PMID: 4012953 (View on PubMed)

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.

Reference Type RESULT
PMID: 1942324 (View on PubMed)

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.

Reference Type RESULT
PMID: 8633417 (View on PubMed)

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.

Reference Type RESULT
PMID: 11597531 (View on PubMed)

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.

Reference Type RESULT
PMID: 16849106 (View on PubMed)

Other Identifiers

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ECKIRB1050505

Identifier Type: -

Identifier Source: org_study_id

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