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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

NCT06245603 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-02-06

No results posted yet for this study

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.

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.

Conditions

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Fidia Farmaceutici s.p.a.

    collaborator INDUSTRY

  • Istituto Oncologico Veneto IRCCS

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-20
Primary Completion
2026-12-31
Completion
2027-06-30

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06245603 on ClinicalTrials.gov