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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

RecruitingNAAges 18 Years - anyAllIstituto Oncologico Veneto IRCCS
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In plain words

What the trial is, and whether it could suit you

Prior to performing any study specific procedure (including screening procedures to determine eligibility), a signed consent form will be obtained for each subject. Patients will be enrolled in the study only if they meet all the inclusion criteria and none of the exclusion criteria. Prior to perform any study specific procedure (including screening procedures to determine eligibility), a signed informed consent form will be obtained for each subject. The informed consent form will describe the purpose of the study, the procedures to be followed, and the risk and benefits of participation. The investigator will conduct the informed consent discussion and will check that the subject comprehends the information provided and will answers any questions about the study. Consent will be voluntary and free from coercion. The investigator that will conduct the consent discussion will also sign

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Male or female ≥ 18 years of age * ECOG PS 0-2 * Histologically confirmed diagnosis of non-muscle invasive bladder cancer, naïve and recurrent. * Patients candidate to BCG or MMC intravesical induction therapy. * Transurethral resection (TURB/re-TURB when indicated) performed in the last 12 weeks. * IPSS score ≤19 * Negative urine culture within 2 weeks before T0 * For women who are not postmenopausal (i.e., \< 1 year after last menstruation) or surgical-ly sterile (absence of ovaries and/or uterus) and who are sexually active: agreement to use an adequate method of contraception (oral contraceptives, intrauterine contraceptive de-vice, or barrier method of contraception in conjunction with spermicidal jelly) during the study period * Signed the study informed consent prior to any study specific procedures. * Will and ability to comply with the protocol Exclusion Criteria: * Upper urinary tract urothelial carcinoma (UTUC); bladder diverticula; urethral stenosis; difficult catheterization; reduced bladder compliance; increased bladder compliance; post-voiding residue \> 150 ml; * Surgery or invasive procedures planned during the study and interfering with evaluation about efficacy and safety of it. * Female patients with child-bearing potential must not be pregnant or lactating, or not willing to use adequate contraception for the duration of study * Pelvic radiotherapy within 24 weeks prior to the beginning of the study treatment. * Urinary tract infection requiring antibiotics * Have a known hypersensitivity to any substance present in the investigational device. * Neurogenic bladder * Any condition for that, in the opinion of the Investigator, participation would not be in the best interest of the subject.
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What it tests

  • Hydeal Cyst®
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Where

9 sites
Humanitas Gavezzeni-Bergamo
Bergamo, Italy
Ospedale Sant'Orsola - Malpighi
Bologna, Italy
Policlinico Ospedali Riuniti - Foggia
Foggia, Italy
Istituto Oncologico Veneto IRCCS
Padova, Italy
Azienda Ospedale Università Padova
Padova, Italy
Ospedali Riuniti Padova Sud
Padova, Italy
Policlinico Paolo Giaccone
Palermo, Italy
Ospedale Santa Maria della Misericordia - ASU FC
Udine, Italy

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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