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

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

January 26, 2006

Start Date ^ICMJE

March 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00166361 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Ureteral Obstruction

Intervention ^ICMJE

Device: Memokath 051 Ureteral Stent

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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 ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00166361

Responsible Party

Study ID Numbers ^ICMJE

255-03

Study Sponsor ^ICMJE

Mayo Clinic

Collaborators ^ICMJE

Engineers & Doctors Wallsten Medical Group

Investigators ^ICMJE

Principal Investigator:

Lance A Mynderse, M.D.

Mayo Clinic

Information Provided By

Mayo Clinic

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP