Evaluating Hydeal Cyst® for Bladder Cancer Treatment

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

This study is testing if a new treatment called Hydeal Cyst® can help people with non-muscle invasive bladder cancer who are already getting chemotherapy or immunotherapy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Istituto Oncologico Veneto IRCCS (other)
• Locations: 9 sites (Bergamo and 8 other locations)
• Trial ID: NCT06245603 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of Hydeal Cyst® intravesical instillations in patients with non-muscle invasive bladder cancer who are undergoing intravesical chemotherapy or immunotherapy. Participants will be required to provide informed consent and meet specific inclusion criteria, including a confirmed diagnosis and recent surgical intervention. The study aims to assess the treatment's impact on patient outcomes and overall health.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of non-muscle invasive bladder cancer who are eligible for intravesical therapy.

Not a fit: Patients with upper urinary tract urothelial carcinoma or those with specific urinary tract conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with non-muscle invasive bladder cancer undergoing chemotherapy or immunotherapy.

How similar studies have performed: While this approach is being evaluated, similar studies have shown promise in improving treatment outcomes for bladder cancer patients.

Eligibility criteria

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.

Where this trial is running

Bergamo and 8 other locations

• Humanitas Gavezzeni-Bergamo — Bergamo, Italy (RECRUITING)
• Ospedale Sant'Orsola - Malpighi — Bologna, Italy (NOT_YET_RECRUITING)
• Policlinico Ospedali Riuniti - Foggia — Foggia, Italy (RECRUITING)
• Istituto Oncologico Veneto IRCCS — Padova, Italy (RECRUITING)
• Azienda Ospedale Università Padova — Padova, Italy (RECRUITING)
• Ospedali Riuniti Padova Sud — Padova, Italy (RECRUITING)
• Policlinico Paolo Giaccone — Palermo, Italy (RECRUITING)
• Ospedale Santa Maria della Misericordia - ASU FC — Udine, Italy (RECRUITING)
• Azienda Ospedaliera Universitaria Integrata - Verona — Verona, Italy (RECRUITING)

Study contacts

• Study coordinator: Antonio Amodeo, MD

Conditions: Non-muscle Invasive Bladder Cancer