Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent - Tabular View

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Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent

This study is currently recruiting participants.

Study NCT00166361. Last updated on January 26, 2006. Information provided by Mayo Clinic

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent

Official Title ^†

Long-Term Temporary Drainage of Malignant Extrinsic Ureteral Obstruction Secondary to Inoperable Pelvic or Abdominal Malignancies Using the Memokath 051 Ureteral Stent

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 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.

Detailed Description

Study Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment

Primary Outcome Measure ^†

Treatment efficacy in relief of extrinsic ureteral obstruction in comparison to historic efficacy of standard double-J plastic ureteral stents as cited in the urologic literature
Perioperative and postoperative complications and side effect profiles, including failure of stent insertion, complications of stent insertion, and postoperative complications

Secondary Outcome Measure ^†

Condition ^†

Ureteral Obstruction

Intervention ^†

Device: Memokath 051 Ureteral Stent

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

Start Date ^†

March 2004

Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Presence of extrinsic ureteral obstruction secondary to inoperable pelvic or abdominal malignancy.
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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00166361

Organization ID

255-03

Secondary IDs ^††

Study Sponsor ^†

Mayo Clinic

Collaborators ^††

Engineers & Doctors Wallsten Medical Group

Investigators ^†

Principal Investigator:

Lance A Mynderse, M.D.

Mayo Clinic

Information Provided By

Mayo Clinic

Verification Date

September 2005

First Received Date ^†

September 12, 2005

Last Updated Date

January 26, 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.