Study Evaluating the Efficacy of Synergo Radiofrequency-Induced Thermochemotherapy

Build status - In Progress

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

Find a site

Your Information has been sent successfully.

We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.

Would you like to be notified about other trials? Sign up for Patient Notification Services.

Send a message

Enter your contact details to connect with study team

View email

Phone

View phone

Primary Contact

First name*

Last name*

Email*

Phone number*

Preferred way of contact

Race

Ethnicity

Are you Healthy Volunteer

Are you comfortable with the informed consent process?

Yes

Other language

By sending a message, I agree that my data will be sent to a representative for the selected site and processed in accordance with this website's Privacy Policy (see link in footer).

Interested in the study

Select a study center that’s convenient for you, and get in touch with the study team.

Contact a study center

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)

Brief description of study

Eligibility of study

Find a site

Interested in the study