Clinical Investigation of the Multi4 System

Last updated: April 7, 2025
Sponsor: Multi4 Medical Ab
Overall Status: Completed

Phase

N/A

Condition

Bladder Cancer

Urothelial Carcinoma

Urothelial Cancer

Treatment

Multi4

Clinical Study ID

NCT06136312
CI-02-23-0002
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Previous bladder cancer Ta/T1 G1-3

  • Recurrence of urinary superficial/ non-muscle-invasive bladder cancer visible atcystoscopy, estimated size < 10 mm

  • Willingness and ability to provide informed consent

  • Age ≥18 years

Exclusion

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 complianceperspective to participate in this investigation

Study Design

Total Participants: 18
Treatment Group(s): 1
Primary Treatment: Multi4
Phase:
Study Start date:
December 01, 2023
Estimated Completion Date:
April 02, 2025

Study 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.

Connect with a study center

  • Sahlgrenska University Hospital

    Gothenburg,
    Sweden

    Site Not Available

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