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Tests treatment safety and results for Non-muscle Invasive Bladder Cancer
Official title 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
ClinicalTrials.gov ID: NCT06245603
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- Upper urinary tract urothelial carcinoma (UTUC); bladder diverticula; urethral stenosis; difficult catheterization; reduced bladder compliance...
- Surgery or invasive procedures planned during the study and interfering with evaluation about how well it works 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.
See the full eligibility 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...
- Signed the study informed consent prior to any study specific procedures.
- Will and ability to comply with the protocol
- 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 how well it works 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bergamo, Italy
- Bologna, Italy
- Foggia, Italy
- Padova, Italy
- Palermo, Italy
- Udine, Italy
- Verona, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bergamo, Italy; Bologna, Italy; Foggia, Italy; Padova, Italy; Palermo, Italy; Udine, Italy and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.