UnknownPhase 4

Efficacy and Safety of a Covered Self-expandable Dual-layered Metallic Mesh Stent (UVENTA) in Ureteral Obstruction

South Korea92 participantsStarted 2012-06

Plain-language summary

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.

Who can participate

Age range20 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

✕. Patients with Urothelial Carcinoma
✕. Patients with bladder invasion of malignant tumor
✕. Patients with bladder dysfunction or obstruction of lower urinary tract
✕. one or more times Recurrent Urinary stone in the last 3 years
✕. 2 or more times upper urinary tract infection without upper urinary tract obstruction
✕. Karnofsky scores \< 60
✕. Patients with Bacteriuria
✕. Inadequate Patient to participate in the study as judged by the investigator

What they're measuring

Primary patency rate

Timeframe: 12 months

Trial details

NCT IDNCT01788865

SponsorSamsung Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-06

Contact for this trial

Deok Hyun Han, M.D.

82-2-3410-6431 deokhyun.han@gmail.com

View on ClinicalTrials.gov More Ureteral Obstruction trials