Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent

This study has been completed.
Sponsor:
Collaborator:
Pnn Medical A/S
Information provided by (Responsible Party):
Lance A. Mynderse, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00166361
First received: September 12, 2005
Last updated: June 19, 2014
Last verified: June 2014
  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
Device: JJ Stent

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group 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:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Mean Stent Dwell Time [ Time Frame: baseline to 59 months after placement of stent ] [ Designated as safety issue: No ]
    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.


Enrollment: 29
Study Start Date: February 2004
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Memokath 051 Ureteral Stent
Subjects assigned to this arm received a Memokath 051 Ureteral Stent.
Device: Memokath 051 Ureteral 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.
Active Comparator: JJ Stent
Subjects assigned to this arm received a JJ stent.
Device: JJ Stent
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.
Other Name: Double J stent

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Presence of extrinsic ureteral obstruction

    1. secondary to inoperable pelvic or abdominal malignancy or
    2. 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
  2. Life expectancy greater than 4 months
  3. Adult patient (18 years of age or older)
  4. Preoperative medical examination clearing the patient for general anesthesia
  5. No active urinary tract infection by urinalysis and urine culture.

Exclusion Criteria:

  1. Ureteral obstruction of a benign or intrinsic etiology
  2. Lower urinary tract abnormality precluding cystoscopic stent placement
  3. Patients with a solitary kidney
  4. Patients not willing or unable to receive their post-operative follow-up at the Mayo Clinic in Rochester, Minnesota
  5. Pregnant female patient.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 A/S
Investigators
Principal Investigator: Lance A Mynderse, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Lance A. Mynderse, MD, Consultant in Urology (Surgical), Mayo Clinic
ClinicalTrials.gov Identifier: NCT00166361     History of Changes
Other Study ID Numbers: 255-03
Study First Received: September 12, 2005
Results First Received: June 19, 2014
Last Updated: June 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
Extrinsic ureteral obstruction
Memokath 051 Ureteral Stent
JJ Stent
Stent

Additional relevant MeSH terms:
Ureteral Obstruction
Ureteral Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 20, 2014