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Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent

This study has been completed.
Sponsor:
Collaborator:
Pnn Medical DK
Information provided by (Responsible Party):
Lance A. Mynderse, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00166361
First received: September 12, 2005
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Ureteral Obstruction
 Device: Memokath 051 Ureteral Stent

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-Term Temporary Drainage of Malignant Extrinsic Ureteral Obstruction Secondary to Inoperable Pelvic or Abdominal Malignancies Using the Memokath 051 Ureteral Stent

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 [ Time Frame: baseline to 12 months ] [ Designated as safety issue: Yes ]
  • Perioperative and postoperative complications and side effect profiles, including failure of stent insertion, complications of stent insertion, and postoperative complications [ Time Frame: baseline to 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: March 2004
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Memokath 051 Ureteral Stent
    The Memokath 051 ureteral stent will be placed in a retrograde fashion through a cystoscope and under fluoroscopic guidance under general anesthesia as an outpatient procedure by a single surgeon
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00166361

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Pnn Medical DK
Investigators
Principal Investigator: Lance A Mynderse, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Lance A. Mynderse, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00166361     History of Changes
Other Study ID Numbers: 255-03
Study First Received: September 12, 2005
Last Updated: January 15, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ureteral Obstruction
Ureteral Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013