CompletedNot Applicable

Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent

United States29 participantsStarted 2004-02

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean Stent Dwell Time

Timeframe: baseline to 59 months after placement of stent

Trial details

NCT IDNCT00166361

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-11

Results submitted2014-06-19

View on ClinicalTrials.gov More Ureteral Obstruction trials