Non-muscle Invasive Bladder CancerHydeal CystNCT06245603
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
A study testing Hydeal Cyst® in people with Non-muscle Invasive Bladder Cancer, run by Istituto Oncologico Veneto IRCCS at 9 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-muscle Invasive Bladder Cancer
- What is being tested?
- Hydeal Cyst®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 9 sitesItaly
- Study dates
- 20 Dec 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
Italy9 sites, 9 recruiting
- Recruiting
Humanitas Gavezzeni-Bergamo
Bergamo, 24125
Angelo Porreca, MD, 0354204500 ext. +39, angelo.porreca@hunimed.eu
- Not yet recruiting
Ospedale Sant'Orsola - Malpighi
Bologna
Francesco Chessa, MD, 0512142545 ext. +39, francesco.chessa@aosp.bo.it
Francesco Chessa, MD
- Recruiting
Policlinico Ospedali Riuniti - Foggia
Foggia
Gian Maria Busetto, MD, gianmaria.busetto@unifg.it
Gian Maria Busetto, MD
- Recruiting
Istituto Oncologico Veneto IRCCS
Padova, 35128
Antonio Amodeo, MD, 0423 421321 ext. +39, antonio.amodeo@iov.veneto.it
Gian Luca De Salvo, MD, 049 8215710 ext. +39, gianluca.desalvo@iov.veneto.it
- Recruiting
Azienda Ospedale Università Padova
Padova
Fabrizio Dal Moro, MD, 0498218599 ext. +39, fabrizio.dalmoro@unipd.it
Fabrizio Dal Moro, MD
- Recruiting
Ospedali Riuniti Padova Sud
Padova
Nicola Zanovello, MD, 0429715516 ext. +39, nicola.zanovello@aulss6.veneto.it
Nicola Zanovello, MD
- Recruiting
Policlinico Paolo Giaccone
Palermo, 90127
Nicola Pavan, Prof, nicola.pavan@unipa.it
- Recruiting
Ospedale Santa Maria della Misericordia - ASU FC
Udine
Alessandro Crestani, MD, 0432552931 ext. +39, alessandro.crestani@asufc.sanita.fvg.it
Alessandro Crestani, MD
- Recruiting
Azienda Ospedaliera Universitaria Integrata - Verona
Verona
Alessandro Antonelli, MD, 0458127702/03 ext. +39, alessandro.antonelli@aovr.veneto.it
Alessandro Antonelli, MD
About this study
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 the informed consent form. A copy of the informed consent form will be given to the subject and the fact that the subject has been consented to the study will be documented in the subject's record. When all the inclusion and exclusion criteria have been addressed and the eligibility of the subject confirmed, the subject may be enrolled in the study.
Read more
The following activities and/or assessments will be performed during screening, prior the treatment period start: demographic, medications related to the disease or symptoms and cancer history data collection; Urine-colture; randomization; Questionnaires QoL e IPSS.
BCG or MMC will be started within 1-2 weeks from randomization (within 12-14 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.
After 2 weeks from BCG or MMC instillation end, IPSS e QoL questionaires will be administered and a control urino-colture will be executed.
After 6 and 18 weeks from instillation therapy end, a control visit will be made.
A physical examination will be performed and symptoms evaluated: changes from baseline and abnormalities will be recorded in patient notes.
Control cystoscopy and urino-colture will be executed (as for clinical practice) and IPSS and quality of life evaluated.
- Conditions
- Non-muscle Invasive Bladder Cancer
- Being tested
- Hydeal Cyst®
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydeal Cyst®Device
BCG or MMC will be started within 1-2 weeks from randomization (within 12-14 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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A (interventional arm) | Experimental | patients receive Hydeal Cyst intravesical instillations during the BCG or MMC therapy period. Receives: Device: Hydeal Cyst® |
| Arm B (control arm) | No intervention | patients receive only standard therapy (BCG or MMC). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower urinary tract symptoms
Lower urinary tract symptoms will be evaluated by the IPSS questionnaire (score 0-35) at baseline and follow-up visits. Difference from baseline will be calculated at two weeks after the end of induction cycle of intravesical instillation.
Measured: From the date of randomization up to 22 weeks
Secondary outcomes (4)
Recurrence free survival (RFS)
The recurrence free survival (RFS) will be determined as the time from the date of randomization to the date of clinical disease recurrence. Patients without a RFS event at the time of analysis will be censored at the date of last assessment
Measured: From the date of randomization up to 22 weeks
Progression free survival (PFS)
The progression free survival (PFS) will be determined as the time from the date of randomization to the date of clinical disease progression. Patients without a PFS event at the time of analysis will be censored at the date of last assessment
Measured: From the date of randomization up to 22 weeks
Toxicity during the treatment
Toxicity during the treatment will be recorded and graded according to the NCI-Common Terminology Criteria for Adverse Events (CTCAE) v.5. Grade refers to the severity of the adverse event. A grading (severity) scale is provided for each adverse event term. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE.
Measured: From the date of randomization up to 22 weeks
Quality of Life assessment
Quality of Life will be evaluated at randomization (T0), at weeks 4 and 6/8 (T6 for BCG/T8 for MMC) of instillation treatment and during follow-up period (weeks 2, 6 and 12 after instillation treatment end). QoL will be assessed throught the FACT-Bl questionnaire.
Measured: From the date of randomization up to 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start20 Dec 2024
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-muscle Invasive Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentre open-label, controlled, randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Oncologico Veneto IRCCS
- Sponsor type
- University, hospital or other
- Collaborators
- Fidia Farmaceutici s.p.a.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245603
- Sponsor's protocol ID
- IOV-NMIBC-01-2022-HydealCyst
- Acronym
- Hydeal Cyst
- Status last verified
- Aug 2026
- First submitted
- 19 Jan 2024
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- Hydeal Cyst / IOV-NMIBC-01-2022-HydealCyst
- Conditions
- Non-muscle Invasive Bladder Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Istituto Oncologico Veneto IRCCSUniversity, hospital or other
- Collaborators
- Fidia Farmaceutici s.p.a.
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 the informed consent form. A copy of the informed consent form will be given to the subject and the fact that the subject has been consented to the study will be documented in the subject's record. When all the inclusion and exclusion criteria have been addressed and the eligibility of the subject confirmed, the subject may be enrolled in the study.
The following activities and/or assessments will be performed during screening, prior the treatment period start: demographic, medications related to the disease or symptoms and cancer history data collection; Urine-colture; randomization; Questionnaires QoL e IPSS.
BCG or MMC will be started within 1-2 weeks from randomization (within 12-14 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.
After 2 weeks from BCG or MMC instillation end, IPSS e QoL questionaires will be administered and a control urino-colture will be executed.
After 6 and 18 weeks from instillation therapy end, a control visit will be made.
A physical examination will be performed and symptoms evaluated: changes from baseline and abnormalities will be recorded in patient notes.
Control cystoscopy and urino-colture will be executed (as for clinical practice) and IPSS and quality of life evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicentre open-label, controlled, randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Arm A (interventional arm) | Experimental | Device: Hydeal Cyst®patients receive Hydeal Cyst intravesical instillations during the BCG or MMC therapy period. |
| Arm B (control arm) | No intervention | –patients receive only standard therapy (BCG or MMC). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydeal Cyst®BCG or MMC will be started within 1-2 weeks from randomization (within 12-14 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. | Device | Arm A (interventional arm) |
Primary outcome
Lower urinary tract symptoms
Time frame: From the date of randomization up to 22 weeks
Lower urinary tract symptoms will be evaluated by the IPSS questionnaire (score 0-35) at baseline and follow-up visits. Difference from baseline will be calculated at two weeks after the end of induction cycle of intravesical instillation.
4 secondary outcomes
Recurrence free survival (RFS)
Time frame: From the date of randomization up to 22 weeks
Progression free survival (PFS)
Time frame: From the date of randomization up to 22 weeks
Toxicity during the treatment
Time frame: From the date of randomization up to 22 weeks
Quality of Life assessment
Time frame: From the date of randomization up to 22 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydeal Cyst® in people with Non-muscle Invasive Bladder Cancer, run by Istituto Oncologico Veneto IRCCS at 9 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio Amodeo, MD (0423 421321 ext. +39, antonio.amodeo@iov.veneto.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower urinary tract symptoms (time frame: From the date of randomization up to 22 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.