Skip to content

Randomized controlled trial to evaluate the efficacy and safety of silicon-covered metallic mesh stent compared to conventional polymeric stent in malignant ureteral obstruction patients

Randomized controlled trial to evaluate the efficacy and safety of silicon-covered metallic mesh stent compared to conventional polymeric stent in malignant ureteral obstruction patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0004254
Enrollment
76
Registered
2019-08-28
Start date
2020-01-02
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Insert a silicone covered metal stent or plastic stent into a urethral occlusion patient caused by a malignant tumor.

Sponsors

S&G Biotech
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients under the age of 20 and under 80 who understood the purpose of the clinical trial and signed a written consent form upon voluntary consent. 2) Patients with expected life expectancy of more than 3 months 3) Patients who have not previously undergone metal ureter stent insertion 4) Patients diagnosed with urethral stenosis due to malignant tumors

Exclusion criteria

Exclusion criteria: 1) If diagnosed with urinary epithelial cancer 2) In case of bladder erosion of a malignant tumor 3) In case of past history of Kidney transmission 4) Patients with bladder function including reduction of bladder flow rate 5) Patients with ECOG performance status greater than 3 6) A woman who is likely to become pregnant, a woman who breast-feeds a baby. 7) If the researcher believes that the research is not suitable for carrying out the research

Design outcomes

Primary

MeasureTime frame
primary patency rate

Secondary

MeasureTime frame
Technical success rate;Final patency rate;Primary patency rate;Adverse event;discomfort caused by stent;Patient survival rate for 6 months after treatment

Countries

Korea, Republic of

Contacts

Public ContactDeok Hyun Han

Samsung Medical Center

deokhyun.han@samsung.com+82-2-3410-6431

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026