Clinical Investigation of the Multi4 System

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

Study Overview

• Status: Not yet recruiting
• Conditions: Bladder Cancer
• Intervention / Treatment: Device: Multi4

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 Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Miden Melle-Hannah, MD PhD; Phone Number: +46-736-929000; Email: miden@multi4.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multi4 procedure; Complete TURBT procedure performed in local anesthesia with Multi4 instrument via flexible cystoscopy	Device: Multi4; TURBT procedure performed with the Multi4 instrument in local anesthesia

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Multi4 Medical Ab
• Collaborators: Key2Compliance
• Investigators: Principal Investigator: Henrik Kjölhede, MD PhD, Sahlgrenska University Hospital, Sweden

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: November 14, 2023
• First Posted (Estimated): November 17, 2023

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: CI-02-23-0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No