Clinical trial · Interventional
Incontinent Urinary Diversion Using an Autologous Neo-Urinary Conduit
A Phase 1 Open Label Exploratory Study of an Autologous Neo-Urinary Conduit in Subjects Requiring Incontinent Urinary Diversion Following Radical Cystectomy
NCT01087697CI-TRIAL-00016310completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neo-Urinary Conduit | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Implanted with NUC
- description
- Patients who have been implanted with the Neo-Urinary Conduit
- interventionNames
- Device: Neo-Urinary Conduit
Primary outcomes (1)
- measure
- Structural integrity and conduit patency
- timeFrame
- 12 months post implantation
- description
- CT scan will be used to demonstrate that urine is able to flow safety through the NUC
Secondary outcomes (4)
- measure
- Structural integrity and conduit patency
- timeFrame
- month 12 through month 60 post implantation
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.