Evaluating Hydeal Cyst® for Bladder Cancer Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Humanitas Gavezzeni-Bergamo
  Bergamo, Italy 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

Study contacts

• Study coordinator: Antonio Amodeo, MD
• Email: antonio.amodeo@iov.veneto.it
• Phone: 0423 421321

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• NMIBC sample collection to test cancer monitoring biomarkers

  This study tests a blood, urine, and tumor tissue collection approach in people with high-risk non-muscle invasive bladder cancer to see if a molecular test can detect residual disease and monitor recurrence.

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• Sequential Gemcitabine Plus Docetaxel vs Gemcitabine Plus Mitomycin C for BCG-Unresponsive NMIBC

  This study tests whether adding docetaxel after gemcitabine is better or worse than adding mitomycin C after gemcitabine for people with BCG-unresponsive high-grade non-muscle-invasive bladder cancer.

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• Is ongoing systemic immunotherapy needed after achieving tumor-free status in very-high-risk NMIBC?

  This study tests whether patients who have become tumor-free after a systemic immunotherapy-based bladder-sparing treatment can safely stop therapy and instead be watched closely.

  Recruiting at 4 sites Phase 2 Tianjin Medical University Second Hospital · Tianjin and 3 other locations · NCT07625527

• Comparing CT and MRI with VI-RADS for Bladder Cancer Staging

  This study tests how well CT and MRI with VI-RADS can correctly stage bladder cancer before surgery in adults.

  Recruiting Oslo University Hospital · Oslo · NCT07602010

• How bladder microbes and immune signals affect lower urinary tract health

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  Recruiting University of Zurich · Zurich, Canton of Zurich · NCT07494864

• Cretostimogene for BCG‑unresponsive high‑grade non‑muscle‑invasive bladder cancer

  This treatment will test cretostimogene plus n‑dodecyl‑β‑D‑maltoside in adults whose high‑grade non‑muscle‑invasive bladder cancer did not respond to BCG (carcinoma in situ with or without Ta/T1 tumors).

  Recruiting at 14 sites Phase 2 Lepu Biopharma Co., Ltd. · Beijing, Beijing Municipality and 13 other locations · NCT07283835

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.