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| Name | Class |
|---|---|
| Taewoong Medical Co., Ltd. | INDUSTRY |
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The purpose of this study is to evaluate Efficacy and Safety of a covered self-expandable dual-layered metallic mesh stent (UVENTA) in ureteral obstruction.
Prospective, Multi-center, open label, single arm Study
Treatment
- Covered self-expandable dual-layered metallic mesh Stents(cSEMS) are implanted in patents with malignant ureteral obstruction
Follow up
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cSEMS | Experimental | Patients with malignant ureteral obstruction have cSEMS(Covered self-expandable dual-layered metal stent) implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cSEMS(Covered self-expandable dual-layered metal stent) implant | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary patency rate | Rate of Ureter units maintaining patency without interventions after technical success of the primary procedure(Diuretic RI scan: T½ < 20 min) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success rate | Rate of technical success(each Ureter) resolving the stenosis and passing the contrast medium from the kidney to urinary bladder | 1week, 1 month |
| Final patency rate | Rate of Ureter units maintaining patency without interventions aside from re-stenting(investigational device) after technical success of the primary procedure(Diuretic RI scan: T½ < 20 min) |
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Inclusion Criteria:
Patients who voluntarily agree to participation and submitted a written informed consent for this study, and 20~80 years
One out of following cases below apply to Patients who have malignant ureteral obstruction or have benign ureteral obstruction without improvement after previous treatment
Patients with no previous ureteral metal stenting procedure experience.
Patients with more than 6 months of life expectancy
Patients understanding the objective of the study and who are willing to sign a consent
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deok Hyun Han, M.D. | Contact | 82-2-3410-6431 | deokhyun.han@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Deok Hyun Han, M.D. | Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine | Principal Investigator |
| Hyeong keun Park, M.D. Ph.D. | Department of Urology, Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Recruiting | Seoul | South Korea |
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| 12 months |
| Adverse Event | Rate of total Adverse Events and Adverse Events relevant to Investigational Device | 1week, 1, 3, 6, 9, 12 months |
| Predictive Risk Factors for Primary patency rate | Age, Sex, type of tumor(benign/malignant), length of stenosis, location of stenosis, UVJ cross, balloon catheterization, etc. | 12 months |
| the primary patency rate among different location of distal stent | difference of the primary patency between the group of Distal stent located in urinary bladder and ureter | 12 months |
| Ureteral stent symptom questionnaire(USSQ) | Comparative analysis of USSQ : before procedure and after procedure | 1, 3, 6, 9, 12 months |
| Samsung Medical Center | Recruiting | Seoul | South Korea |
|
| ID | Term |
|---|---|
| D014517 | Ureteral Obstruction |
| ID | Term |
|---|---|
| D014515 | Ureteral Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D016254 | Mutagenesis, Insertional |
| ID | Term |
|---|---|
| D015202 | Protein Engineering |
| D005818 | Genetic Engineering |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D009154 | Mutation |
| D014644 | Genetic Variation |
| D055614 | Genetic Phenomena |
| D016296 | Mutagenesis |
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