Clinical Investigation of the Multi4 System

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06136312
• Other study ID #: CI-02-23-0002
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: November 2023
• Source: Multi4 Medical Ab
• Contact: Miden Melle-Hannah, MD PhD
• Phone: +46-736-929000
• Email: miden[@]multi4.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Device:
• Multi4
TURBT procedure performed with the Multi4 instrument in local anesthesia

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Multi4 Medical Ab	Key2Compliance

Outcome

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