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Completed

NCT Number: NCT06136312

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

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Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital

Gothenburg, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multi4

Device

TURBT procedure performed with the Multi4 instrument in local anesthesia

Primary outcomes

  1. Evaluable biopsies

    Time frame: At procedure

    Biopsies collected by the instrument are evaluable by pathologist

Secondary outcomes

  1. Number of participants with treatment-related adverse events

    Time frame: One week

    Frequency and severity of adverse events related to instrument use

  2. Number of patients with complete procedures performed

    Time frame: At procedure

    Proportion of procedures that can be completely performed with the instrument

  3. Patient-reported treatment-related pain (numeric rating scale)

    Time frame: At procedure

    Patient reported pain experienced during procedure, from 0 (no pain) to 10 (worst possible pain)

  4. Quality of life (EQ-5D-5L)

    Time frame: 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

  5. Time to perform procedure

    Time frame: At procedure

    Time taken to perform a complete procedure

  6. Time for patient surveillance

    Time frame: At procedure

    Time taken for observation after procedure

  7. Self reported satisfaction with procedure

    Time frame: 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

  8. Operator-reported ease of use

    Time frame: 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)

  9. Cost effectiveness

    Time frame: At procedure

    Total costs associated with procedure compared to a complete TURBT in general anesthesia

Sponsors and collaborators

Lead sponsor

Multi4 Medical Ab

Industry

Collaborators

  • Key2Compliance

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 18, 2023
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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