Incontinent Urinary Diversion Using an Autologous Neo-Urinary Conduit

NCT01087697 | Completed Phase 1 DMC

• 1 other identifier: TNG-CL009
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to see if the Neo-Urinary Conduit(NUC), which is made in the laboratory from a combination of a patient's own cells and other materials can be used to form a conduit to safety allow urine flow from the kidneys to outside the body after radical cystectomy in patients with bladder cancer.

Conditions

Bladder Cancer

Keywords

bladder cancer; radical cystectomy; incontinent urinary diversion

Outcome Measures

Primary Outcomes (1)

• Structural integrity and conduit patency

  CT scan will be used to demonstrate that urine is able to flow safety through the NUC

  12 months post implantation

Secondary Outcomes (4)

• Structural integrity and conduit patency

  month 12 through month 60 post implantation

• Procedure and/or product related AEs

  month 12 through month 60 post implant

• Overall safety

  from enrollment through month 60 post implant

• Procedure and/or product related adverse events post implantation

  through 12 months post implantation

Study Arms (1)

Implanted with NUC

EXPERIMENTAL

Patients who have been implanted with the Neo-Urinary Conduit

Device: Neo-Urinary Conduit

Interventions

Neo-Urinary Conduit DEVICE

Implantation with the autologous Neo-Urinary Conduit

Also known as: NUC

Implanted with NUC

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects 18 - 80 years of age
• Patients undergoing radical cystectomy for treatment of bladder cancer clinically staged as no greater than T2, N0
• Indicated and agreed between physician investigator and patient to have an incontinent conduit as the diversion mechanism of choice post cystectomy

You may not qualify if:

• History of other cancer within the past 5 years (except non metastatic prostate or non melanoma skin cancer)
• Evidence of cancer metastasis
• History of any pelvic radiation or non-pelvic radiation within past 5 years
• Debilitating cardiac or pulmonary disease
• Expected need for chemotherapy within 3 months post cystectomy
• Life expectancy less than 2 years

Sponsors & Collaborators

• Tengion: lead

Study Sites (6)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

The Johns Hopkins Medical Institutions

Baltimore, Maryland, 21287, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Gary Steinberg, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

• Trinity J Bivalacqua, M.D., Ph.D.

  The Johns Hopkins Medical Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2010
• First Posted: March 16, 2010
• Study Start: March 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 10, 2014

Record last verified: 2014-12

Locations

US (6)