Clinical Investigation of the Multi4 System

NCT ID: NCT06136312

Last Updated: 2025-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2025-04-02

Brief Summary

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

Detailed Description

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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.

Conditions

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Bladder Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Multi4 procedure

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

Group Type EXPERIMENTAL

Multi4

Intervention Type DEVICE

TURBT procedure performed with the Multi4 instrument in local anesthesia

Interventions

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Multi4

TURBT procedure performed with the Multi4 instrument in local anesthesia

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Key2Compliance

INDUSTRY

Sponsor Role collaborator

Multi4 Medical Ab

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Henrik Kjölhede, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital

Locations

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Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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CI-02-23-0002

Identifier Type: -

Identifier Source: org_study_id

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