NCT06136312

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2025

Completed
Last Updated

April 9, 2025

Status Verified

April 1, 2025

Enrollment Period

1.3 years

First QC Date

November 8, 2023

Last Update Submit

April 7, 2025

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

  • Evaluable biopsies

    Biopsies collected by the instrument are evaluable by pathologist

    At procedure

Secondary Outcomes (9)

  • Number of participants with treatment-related adverse events

    One week

  • Number of patients with complete procedures performed

    At procedure

  • Patient-reported treatment-related pain (numeric rating scale)

    At procedure

  • Quality of life (EQ-5D-5L)

    At procedure and after 1 week

  • Time to perform procedure

    At procedure

  • +4 more secondary outcomes

Study Arms (1)

Multi4 procedure

EXPERIMENTAL

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

Device: Multi4

Interventions

Multi4DEVICE

TURBT procedure performed with the Multi4 instrument in local anesthesia

Multi4 procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Henrik Kjölhede, MD PhD

    Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2023

First Posted

November 18, 2023

Study Start

December 1, 2023

Primary Completion

April 2, 2025

Study Completion

April 2, 2025

Last Updated

April 9, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)