Bladder Cancer Clinical Trial
Official title:
A Clinical Investigation to Confirm Performance and Safety of the Multi4 System in Patients With Suspected Recurrent Bladder Cancer Lesions
A Clinical Investigation to Confirm Performance and Safety of the Multi4 System in Patients with Suspected Recurrent Bladder Cancer Lesions
Status | Not yet recruiting |
Enrollment | 25 |
Est. completion date | September 30, 2024 |
Est. primary completion date | March 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Previous bladder cancer Ta/T1 G1-3 - Recurrence of urinary superficial/ non-muscle-invasive bladder cancer visible at cystoscopy, estimated size < 10 mm - Willingness and ability to provide informed consent - Age =18 years Exclusion Criteria: - Implantable Cardioverter Defibrillator (ICD) that cannot be inactivated - Current/ongoing untreated urinary tract infection - Pregnancy or breastfeeding - Be identified by the Investigator as inappropriate from a medical or compliance perspective to participate in this investigation |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Multi4 Medical Ab | Key2Compliance |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluable biopsies | Biopsies collected by the instrument are evaluable by pathologist | At procedure | |
Secondary | Number of participants with treatment-related adverse events | Frequency and severity of adverse events related to instrument use | One week | |
Secondary | Number of patients with complete procedures performed | Proportion of procedures that can be completely performed with the instrument | At procedure | |
Secondary | Patient-reported treatment-related pain (numeric rating scale) | Patient reported pain experienced during procedure, from 0 (no pain) to 10 (worst possible pain) | At procedure | |
Secondary | Quality of life (EQ-5D-5L) | Difference in self reported quality of life with the EuroQol 5-level instrument, prior to procedure compared to one week after procedure | At procedure and after 1 week | |
Secondary | Time to perform procedure | Time taken to perform a complete procedure | At procedure | |
Secondary | Time for patient surveillance | Time taken for observation after procedure | At procedure | |
Secondary | Self reported satisfaction with procedure | Proportion of patients who, in case of further bladder cancer recurrences, would choose to undergo the same procedure in local anesthesia as opposed to a full TURBT in general anesthesia | One week | |
Secondary | Operator-reported ease of use | Number of procedures where to operator reports that the Multi4 instrument works without issue and is easily handled (yes), or whether there are handling issues (no) | At procedure | |
Secondary | Cost effectiveness | Total costs associated with procedure compared to a complete TURBT in general anesthesia | At procedure |
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