Clinical Investigation of the Multi4 System

Multi4 Medical

Status: Completed

Conditions: Bladder Cancer

Treatments: Device: Multi4

Study type: Interventional

Funder types: Industry

Identifiers

NCT06136312

CI-02-23-0002

Details and patient eligibility

About

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

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Multi4 procedure

Experimental group

Description:

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

Treatment:

Device: Multi4