Tandem Polyurethane Stents Compared to Single Silicone Stent for Malignant Ureteral Obstruction
NCT05992363 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106
Last updated 2025-07-24
Summary
Malignant ureteral obstruction (MUO) is an extrinsic ureteral obstruction caused by malignant diseases. This study aim to compare tandem 6 Fr Percuflex™ stents and single large-caliber 8Fr silicone stent in patients with MUO. The primary endpoint is stent failure rate. The secondary endpoints are patient comfort, quality of life and overall survival.
Conditions
- Hydronephrosis; Obstruction, Ureter
- Renal Failure
- Malignancy
- Ureter Obstruction
- Ureter Stricture
Interventions
- DEVICE
-
ureteral stent\s insertion
ureteral stent\\s insertion in the operating room
Sponsors & Collaborators
-
Sheba Medical Center
collaborator OTHER_GOV -
Rabin Medical Center
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-12-20
- Primary Completion
- 2026-12-31
- Completion
- 2027-12-31
- FDA Device
- Yes
Countries
- Israel
Study Locations
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