Status:
COMPLETED
Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Pnn Medical A/S
Conditions:
Ureteral Obstruction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of the Memokath 051 ureteral stent as a long-term temporary and minimally invasive means of providing ureteral drainage in the setting ...
Detailed Description
The Memokath 051 ureteral stent is a device designed to provide long-term temporary ureteral drainage in the setting of extrinsic ureteral obstruction secondary to inoperable pelvic and abdominal mali...
Eligibility Criteria
Inclusion
- Presence of extrinsic ureteral obstruction
- secondary to inoperable pelvic or abdominal malignancy or
- secondary to changes caused by surgery, chemotherapy, or radiation for pelvic and/or abdominal malignancies who have had \>2 standard double J stent exchanges with no prospect of being stent-free
- Life expectancy greater than 4 months
- Adult patient (18 years of age or older)
- Preoperative medical examination clearing the patient for general anesthesia
- No active urinary tract infection by urinalysis and urine culture.
Exclusion
- Ureteral obstruction of a benign or intrinsic etiology
- Lower urinary tract abnormality precluding cystoscopic stent placement
- Patients with a solitary kidney
- Patients not willing or unable to receive their post-operative follow-up at the Mayo Clinic in Rochester, Minnesota
- Pregnant female patient.
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00166361
Start Date
February 1 2004
End Date
November 1 2008
Last Update
July 18 2014
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905