Bladder Cancer
Conditions
Brief summary
A Clinical Investigation to Confirm Performance and Safety of the Multi4 System in Patients with Suspected Recurrent Bladder Cancer Lesions
Detailed description
The overall purpose of this study is to confirm performance and safety of Multi4 Medical Device System when used as intended: to cauterize, remove, and automatically collect multiple tissue samples through the working channel of an endoscope. The safety profile will be documented by collecting data on frequency and severity of complications, AEs such as bleeding and perforations.
Interventions
DEVICEMulti4
TURBT procedure performed with the Multi4 instrument in local anesthesia
Sponsors
Key2Compliance
Multi4 Medical Ab
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluable biopsies | At procedure | Biopsies collected by the instrument are evaluable by pathologist |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with complete procedures performed | At procedure | Proportion of procedures that can be completely performed with the instrument |
| Patient-reported treatment-related pain (numeric rating scale) | At procedure | Patient reported pain experienced during procedure, from 0 (no pain) to 10 (worst possible pain) |
| Quality of life (EQ-5D-5L) | At procedure and after 1 week | Difference in self reported quality of life with the EuroQol 5-level instrument, prior to procedure compared to one week after procedure |
| Time to perform procedure | At procedure | Time taken to perform a complete procedure |
| Number of participants with treatment-related adverse events | One week | Frequency and severity of adverse events related to instrument use |
| Self reported satisfaction with procedure | One week | 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 |
| Operator-reported ease of use | At procedure | 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) |
| Cost effectiveness | At procedure | Total costs associated with procedure compared to a complete TURBT in general anesthesia |
| Time for patient surveillance | At procedure | Time taken for observation after procedure |
Countries
Sweden
Outcome results
None listed