At a glance
ClinicalIndex Comparison Record- ✓Extrinsic ureteral obstruction secondary to inoperable pelvic or abdominal malignancy
- ✓Extrinsic ureteral obstruction secondary to changes from surgery, chemotherapy, or radiation for pelvic/abdominal malignancies with >2 prior standard double J stent exchanges and no prospect of being stent-free
- ✓Life expectancy greater than 4 months
- ✓Age 18 years or older
- ✕Ureteral obstruction of benign or intrinsic etiology
- ✕Lower urinary tract abnormality precluding cystoscopic stent placement
- ✕Solitary kidney
- ✕Unable or unwilling to receive post-operative follow-up at Mayo Clinic in Rochester, Minnesota
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Long-Term Temporary Drainage of Malignant Extrinsic Ureteral Obstruction Secondary to Inoperable Pelvic or Abdominal Malignancies Using the Memokath 051 Ureteral Stent
In Brief
A clinical study evaluating Memokath 051 Ureteral Stent and JJ Stent for Ureteral Obstruction. Completed, enrolled 29 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
The Memokath 051 ureter stent is used for the treatment of malignant or benign ureteric strictures in both men and women. The stent design consists of a tightly-coiled nickel-titanium alloy, with a diameter of 10.5 French (Fr) and a fluted proximal diameter expanding to 22 Fr. The stent is manufactured in multiple lengths which are chosen to position the device across the narrowed area rather than crossing the ureteropelvic or ureterovesical junction. It has a thermal memory system for its predetermined shape; the stent softens at temperatures below 10 degrees Celsius but regains its shape when heated above 55 degrees Celsius.
A JJ stent is a flexible plastic tube that drains urine from the kidney to the bladder and is supposed to stay in place temporarily. There is a coil on each end to keep the stent in place, preventing the stent from migrating down and out from the kidney or up from the bladder into the ureter. The stent can stay in place for few weeks to 3 months or more depending on the indication. If left for more than 6-9 months some stents may get encrusted leading to stone formation around the stent.