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Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent

Primary Purpose

Ureteral Obstruction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Memokath 051 Ureteral Stent
JJ Stent
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ureteral Obstruction focused on measuring Extrinsic ureteral obstruction, Memokath 051 Ureteral Stent, JJ Stent, Stent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: Ureteral obstruction of a benign or intrinsic etiology Lower urinary tract abnormality precluding cystoscopic stent placement Patients with a solitary kidney Patients not willing or unable to receive their post-operative follow-up at the Mayo Clinic in Rochester, Minnesota Pregnant female patient.

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Memokath 051 Ureteral Stent

JJ Stent

Arm Description

Subjects assigned to this arm received a Memokath 051 Ureteral Stent.

Subjects assigned to this arm received a JJ stent.

Outcomes

Primary Outcome Measures

Mean Stent Dwell Time
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.

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
June 19, 2014
Sponsor
Mayo Clinic
Collaborators
Pnn Medical A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00166361
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Pnn Medical A/S

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureteral Obstruction
Keywords
Extrinsic ureteral obstruction, Memokath 051 Ureteral Stent, JJ Stent, Stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Memokath 051 Ureteral Stent
Arm Type
Experimental
Arm Description
Subjects assigned to this arm received a Memokath 051 Ureteral Stent.
Arm Title
JJ Stent
Arm Type
Active Comparator
Arm Description
Subjects assigned to this arm received a JJ stent.
Intervention Type
Device
Intervention Name(s)
Memokath 051 Ureteral Stent
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
JJ Stent
Other Intervention Name(s)
Double J stent
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean Stent Dwell Time
Description
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.
Time Frame
baseline to 59 months after placement of stent

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Ureteral obstruction of a benign or intrinsic etiology Lower urinary tract abnormality precluding cystoscopic stent placement Patients with a solitary kidney Patients not willing or unable to receive their post-operative follow-up at the Mayo Clinic in Rochester, Minnesota Pregnant female patient.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lance A Mynderse, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent

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