Study Evaluating the Efficacy of Synergo Radiofrequency-Induced Thermochemotherapy Effect (RITE) with Mitomycin C (Synergo RITE + MMC) in CIS Non-Muscle Invasive Bladder Cancer (NMIBC)
Recruiting
18 years - 99 years
All
Phase
3
10 participants needed
1 Location
Brief description of study
The objectives of the study are to determine the efficacy and safety of Synergo® RITE and mitomycin C (MMC) in the treatment of carcinoma in situ (CIS) non-muscle invasive bladder cancer in adult patients who didn't respond to 2 courses of treatment with Bacillus Calmette-Guérin (BCG) installations. The Synergo® system is designed for the treatment of NMIBC. Radio waves, emanating from a small antenna embedded in the special disposable Synergo® catheter, continuously heat the bladder walls, while a chemotherapeutic agent (e.g., MMC) is continuously circulated between the bladder and the computer-embedded Synergo® radiofrequency hyperthermia device.
The study will consist of three periods: 1) Screening; 2) Induction treatment (8 weekly treatments of Synergo® RITE + MMC), and 3) Maintenance treatment and follow-up (one Synergo® RITE + MMC treatment every 6 weeks).
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Medical Research
-
Age: 18 years - 99 years
-
Gender: All
Updated on
04 Aug 2024.
Study ID: 832005
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