A Study to Evaluate Efficacy and Safety of Hydeal Cyst® Intravesical Instillations in Patients Treated With Intravesical Chemotherapy or Immunotherapy in Non-muscle Invasive Bladder Cancer

NARecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

December 20, 2024

Primary Completion Date

December 31, 2026

Study Completion Date

June 30, 2027

Conditions
Non-muscle Invasive Bladder Cancer
Interventions
DEVICE

Hydeal Cyst®

"BCG or MMC will be started within 1-2 weeks from randomization (within 4-6 weeks after TURB).~BCG or MMC will be administered once a week by intravesical instillation: BCG will be abministered for 6 weeks and MMC for 8 weeks. (induction cycles) Before instillations a physical examination will be performed and symptoms evaluated: changes from baseline and abnormalities will be recorded in patient notes.~IPSS questionnaire and QoL questionaire will be administered to the patient at week 1, 4 and 6/8 (6 for BCG and 8 for MMC) of treatment.~48 hours after post BCG or MMC intravesical instillation, patients of Arm A will undergo Hydeal Cyst intravesical instillation.~BCG patiens will received 6 Hydeal Cyst intravesical instillation; MMC patiens will received 8 Hydeal Cyst intravesical instillation."

Trial Locations (9)

24125

RECRUITING

Humanitas Gavezzeni-Bergamo, Bergamo

35128

RECRUITING

Istituto Oncologico Veneto IRCCS, Padua

90127

RECRUITING

Policlinico Paolo Giaccone, Palermo

Unknown

NOT_YET_RECRUITING

Ospedale Sant'Orsola - Malpighi, Bologna

RECRUITING

Policlinico Ospedali Riuniti - Foggia, Foggia

RECRUITING

Azienda Ospedale Università Padova, Padua

RECRUITING

Ospedali Riuniti Padova Sud, Padua

RECRUITING

Ospedale Santa Maria della Misericordia - ASU FC, Udine

RECRUITING

Azienda Ospedaliera Universitaria Integrata - Verona, Verona

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Fidia Farmaceutici s.p.a.

INDUSTRY

lead

Istituto Oncologico Veneto IRCCS

OTHER