N/A
N=24
Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent
Ureteral Obstruction
Bottom Line
View on ClinicalTrials.gov: NCT00166361 ↗Enrolled (actual)
24
Serious AEs
58.3%
Results posted
Jul 2014
Primary outcome: Primary: Mean Stent Dwell Time — 17; 3.97 months
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Memokath 051 Ureteral Stent (Device); JJ Stent (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Stent Dwell Time |
17; 3.97 | — |
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 of malignant extrinsic ureteral obstruction secondary to inoperable abdominal or pelvic malignancies. Up to 15 adults who have extrinsic ureteral obstruction secondary to an inoperable abdominal or pelvic malignancy and need ureteral stent drainage will undergo outpatient placement of the ureteral stent. Ongoing monitoring will continue for as long as the stent is in place.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00166361). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.