Clinical Investigation of the Multi4 System

Study Overview
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Brief Summary
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A Clinical Investigation to Confirm Performance and Safety of the Multi4 System in Patients with Suspected Recurrent Bladder Cancer Lesions

Detailed Description
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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.

Official Title
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A Clinical Investigation to Confirm Performance and Safety of the Multi4 System in Patients With Suspected Recurrent Bladder Cancer Lesions

Conditions
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Bladder Cancer

Intervention / Treatment
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* Device: Multi4


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multi4 procedure<br>Complete TURBT procedure performed in local anesthesia with Multi4 instrument via flexible cystoscopy | Device: Multi4<br>* TURBT procedure performed with the Multi4 instrument in local anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluable biopsies | Biopsies collected by the instrument are evaluable by pathologist | At procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events | Frequency and severity of adverse events related to instrument use | One week | 
| Number of patients with complete procedures performed | Proportion of procedures that can be completely performed with the instrument | At procedure | 
| 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 | 
| 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 | 
| Time to perform procedure | Time taken to perform a complete procedure | At procedure | 
| Time for patient surveillance | Time taken for observation after procedure | At procedure | 
| 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 | 
| 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 | 
| Cost effectiveness | Total costs associated with procedure compared to a complete TURBT in general anesthesia | At procedure |