Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent

NCT00166361 | Completed Results DMC

• 1 other identifier: 255-03
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Ureteral Obstruction

Keywords

Extrinsic ureteral obstruction; Memokath 051 Ureteral Stent; JJ Stent; Stent

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline to 59 months after placement of stent

Study Arms (2)

Memokath 051 Ureteral Stent

EXPERIMENTAL

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

Device: Memokath 051 Ureteral Stent

JJ Stent

ACTIVE COMPARATOR

Subjects assigned to this arm received a JJ stent.

Device: JJ Stent

Interventions

Memokath 051 Ureteral Stent DEVICE

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.

Memokath 051 Ureteral Stent

JJ Stent DEVICE

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.

Also known as: Double J stent

JJ Stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• Pnn Medical A/S: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Ureteral Obstruction

Condition Hierarchy (Ancestors)

Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Limitations and Caveats

Low number of subjects in each cohort.

Results Point of Contact

• Title: Dr. Lance A. Mynderse
• Organization: Mayo Clinic

mynderse.lance@mayo.edu

507-284-1250

Study Officials

• Lance A Mynderse, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Consultant in Urology (Surgical)

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 14, 2005
• Study Start: February 1, 2004
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: July 18, 2014
• Results First Posted: July 18, 2014

Record last verified: 2014-06

Locations

US (1)