Clinical Investigation of the Multi4 System

Not Applicable

Completed

• Conditions: Bladder Cancer
• Interventions: Device: Multi4

• Registration Number: NCT06136312
• Lead Sponsor: Multi4 Medical Ab

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.

Study Timeline

• Study First Submitted: 2023-11-08
• Study First Submitted QC: 2023-11-14
• Study First Posted: 2023-11-18
• Study Start: 2023-12-01
• Status Verified: 2025-04
• Primary Completion: 2025-04-02
• Study Completion: 2025-04-02
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Multi4 procedure	Multi4	Complete TURBT procedure performed in local anesthesia with Multi4 instrument via flexible cystoscopy

Primary Outcome Measures

Name	Time	Method
Evaluable biopsies	At procedure	Biopsies collected by the instrument are evaluable by pathologist

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden