Clinical trial · Interventional
Safety and Tolerability Study Which Evaluate Intravesical Instillation With Mitomycin C Mixed With TC-3 Drug Retaining Hydrogel Device In Patients With Muscle Invasive Bladder Cancer
An Open Label Study Evaluating Short Term Safety and Tolerability of Patients With MUSCLE INVASIVE BLADDER CANCER- for Intravesical Instillation Mitomycin c Mixed With Disposable Device Which Prevents Drug Drainage Out of the Patient's Bladder
NCT01648010CI-TRIAL-00010228completedN/AClinicalTrials.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 evaluate the safety of intravesical instillation of TC-3 Hydrogel disposable device for retention of mitomycin C chemotherapeutic drug in the urinary bladder.
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 |
|---|---|---|---|
| Carcinoma of Urinary Bladder, Invasive | Bladder Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TC-3 gel | Device | — | UNRESOLVED |
| TC-3 gel mixed with Mitomycin C (MMC) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TC-3 gel
- description
- TC-3 gel group undergo intravesical instillation of the investigatory device
- interventionNames
- Device: TC-3 gel
- type
- EXPERIMENTAL
- label
- MMC- gel
- description
- MMC gel group undergo intravesical instillation of the reverse thermal gelation device mixed with MMC
- interventionNames
- Device: TC-3 gel mixed with Mitomycin C (MMC)
Primary outcomes (1)
- measure
- Assessment of systemic and urine pharmacokinetics of MMC following intravesical instillation of TC-3 mixed with MMC for safety evaluation.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent form. * Patients with bladder cancer designated to undergo Radical Cystectomy Exclusion Criteria: * Sensitivity to MMC * Acute urinary Tract Infection (UTI) * Upper urinary tract obstruction. * Patient received neoadjuvant treatment previous to Radical Cystectomy * Pregnant women as diagnosed by Beta - HCG, or women that are suspected to be pregnant * Breastfeeding women
References
Publications (0)
Data not yet available
No reference posted for this study.