An interventional study of Memokath 051 Ureteral Stent and JJ Stent in Ureteral Obstruction, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-18.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment
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.
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 malignancies or secondary to changes caused by surgery, chemotherapy, or radiation for pelvic and/or abdominal malignancies. The management of malignant extrinsic ureteral obstruction secondary to inoperable neoplastic disease of the abdomen or pelvis is a common urologic problem, and has important implications for a patient's quality as well as quantity of life, which has been estimated to generally range between 6.5 to 23 months in this population. Currently, extrinsic ureteral obstructions are usually managed with double-J ureteral stents, placed either cystoscopically, or antegrade via a percutaneous nephrostomy tube. Double-J stents are prone to encrustation and obstruction over time, necessitating stent exchange under general anesthesia every 3 to 4 months. These repeat surgical procedures under general anesthesia carry subsequent risks of infection, drug reactions, and iatrogenic injury, leading to degradation in the quality of life of these patients who often have a year or less to live. To circumvent these disadvantages, the nickel-titanium Memokath 051 ureteral stent was developed to provide a means of minimally invasive long-term temporary ureteral drainage.
This is a prospective non-randomized clinical study to evaluate the efficacy of the Memokath 051 ureteral stent in managing extrinsic malignant ureteral obstruction secondary to an inoperable abdominal or pelvic malignancy or secondary to changes caused by surgery, chemotherapy, or radiation for pelvic and/or abdominal malignancies. Enrollment of study subjects will take place over a period of two to three years for to a total of 15 patients.
A control group 10 patients with extrinsic ureteral obstruction secondary to an inoperable pelvic or abdominal malignancy or secondary to changes caused by surgery, chemotherapy, or radiation for pelvic and/or abdominal malignancies and treated by other urologic staff surgeons in a standard fashion with retrogradely placed double-J stents will also be followed every 3 to 4 months.
44 studies on the registry are indexed under Ureteral Obstruction; 9 are open to participants now.
This study's enrollment of 29 is below the median of 52 across 30 interventional studies indexed under Ureteral Obstruction.
Browse Ureteral Obstruction studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 669 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Presence of extrinsic ureteral obstruction
Exclusion Criteria:
Subjects assigned to this arm received a Memokath 051 Ureteral Stent.
Device: Memokath 051 Ureteral Stent
Subjects assigned to this arm received a JJ stent.
Device: JJ Stent
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.
Also known as: Double J stent
Mean Stent Dwell Time
Stent dwell time is defined as the amount of time a stent can remain in the body after it placed, before it needs to be removed due to failure.
Time frame: baseline to 59 months after placement of stent
Patients were recruited from Oncologic practice of the Mayo Clinic, Rochester, Minnesota from February 2004 to May 2011.
| Milestone | Memokath 051 Ureteral Stent | JJ Stent |
|---|---|---|
| Started | 14 | 10 |
| Completed | 14 | 10 |
| Not completed | 0 | 0 |
Stent dwell time is defined as the amount of time a stent can remain in the body after it placed, before it needs to be removed due to failure.
| months | Memokath 051 Ureteral Stent | JJ Stent |
|---|---|---|
| Mean Stent Dwell Time | 17 (1 to 59) | 3.97 (2.56 to 5.36) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Memokath 051 Ureteral Stent | — | 12/14 (85.7%) | 10/14 (71.4%) |
| JJ Stent | — | 2/10 (20%) | 8/10 (80%) |
| Event | Memokath 051 Ureteral Stent | JJ Stent |
|---|---|---|
| Ureteral ObstructionRenal and urinary disorders | 7/14 | 0/10 |
| Bowel ObstructionGastrointestinal disorders | 4/14 | 0/10 |
| Stent encrustation/obstructionInjury, poisoning and procedural complications | 4/14 | 0/10 |
| Hospitalization due to disease progressionRenal and urinary disorders | 3/14 | 0/10 |
| HydroureteronephrosisRenal and urinary disorders | 3/14 | 0/10 |
| Hospitalization for sepsisGeneral disorders | 0/14 | 2/10 |
| Edema of ureterRenal and urinary disorders | 2/14 | 0/10 |
| NephrectomyRenal and urinary disorders | 0/14 | 1/10 |
| Partial ureterectomyRenal and urinary disorders | 0/14 | 1/10 |
| Hospitalization for urinary tract infection (UTI)Renal and urinary disorders | 0/14 | 1/10 |
| Event | Memokath 051 Ureteral Stent | JJ Stent |
|---|---|---|
| Urinary tract infections (UTI)Renal and urinary disorders | 9/14 | 4/10 |
| NauseaGastrointestinal disorders | 8/14 | 0/10 |
| HydronephrosisRenal and urinary disorders | 7/14 | 0/10 |
| Flank painRenal and urinary disorders | 6/14 | 3/10 |
| VomitingGastrointestinal disorders | 6/14 | 0/10 |
| Groin painGeneral disorders | 3/14 | 3/10 |
| HematuriaRenal and urinary disorders | 1/14 | 3/10 |
| Urine leakageRenal and urinary disorders | 0/14 | 3/10 |
| Abdominal painGastrointestinal disorders | 4/14 | 1/10 |
| Left lower quadrant painGeneral disorders | 3/14 | 0/10 |
| Age, Categorical(Participants) | Memokath 051 Ureteral Stent | JJ Stent | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 9 | 0 | 9 |
| >=65 years | 5 | 10 | 15 |
| Sex: Female, Male(Participants) | Memokath 051 Ureteral Stent | JJ Stent | Total |
|---|---|---|---|
| Female | 11 | 7 | 18 |
| Male | 3 | 3 | 6 |
| Region of Enrollment(participants) | Memokath 051 Ureteral Stent | JJ Stent | Total |
|---|---|---|---|
| United States | 14 | 10 | 24 |
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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