Bladder CancerNCT06136312
Clinical Investigation of the Multi4 System
A study testing Multi4 in people with Bladder Cancer, run by Multi4 Medical Ab at 1 site in Sweden.
Trial summary
A Clinical Investigation to Confirm Performance and Safety of the Multi4 System in Patients with Suspected Recurrent Bladder Cancer Lesions Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Multi4
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSweden
- Study dates
- 1 Dec 2023to 2 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Investigation to Confirm Performance and Safety of the Multi4 System in Patients With Suspected Recurrent Bladder Cancer Lesions
A Clinical Investigation to Confirm Performance and Safety of the Multi4 System in Patients with Suspected Recurrent Bladder Cancer Lesions
Read the detailed 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.
- Conditions
- Bladder Cancer
- Being tested
- Multi4
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi4Device
TURBT procedure performed with the Multi4 instrument in local anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Multi4 procedure | Experimental | Complete TURBT procedure performed in local anesthesia with Multi4 instrument via flexible cystoscopy Receives: Device: Multi4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluable biopsies
Biopsies collected by the instrument are evaluable by pathologist
Measured: At procedure
Secondary outcomes (9)
Number of participants with treatment-related adverse events
Frequency and severity of adverse events related to instrument use
Measured: One week
Number of patients with complete procedures performed
Proportion of procedures that can be completely performed with the instrument
Measured: At procedure
Patient-reported treatment-related pain (numeric rating scale)
Patient reported pain experienced during procedure, from 0 (no pain) to 10 (worst possible pain)
Measured: At procedure
Quality of life (EQ-5D-5L)
Difference in self reported quality of life with the EuroQol 5-level instrument, prior to procedure compared to one week after procedure
Measured: At procedure and after 1 week
Time to perform procedure
Time taken to perform a complete procedure
Measured: At procedure
Time for patient surveillance
Time taken for observation after procedure
Measured: At procedure
Self reported satisfaction with procedure
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
Measured: One week
Operator-reported ease of use
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)
Measured: At procedure
Cost effectiveness
Total costs associated with procedure compared to a complete TURBT in general anesthesia
Measured: At procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Dec 2023
- Primary completion2 Apr 2025
- Study completion2 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Multi4 Medical Ab
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Key2Compliance
- Responsible party
- Sponsor
- Investigators
- Henrik Kjölhede, MD PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06136312
- Sponsor's protocol ID
- CI-02-23-0002
- Status last verified
- Apr 2025
- First submitted
- 8 Nov 2023
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Investigation to Confirm Performance and Safety of the Multi4 System in Patients With Suspected Recurrent Bladder Cancer Lesions
- ClinicalTrials.gov ID
- NCT06136312
- Acronym / sponsor ID
- CI-02-23-0002
- Conditions
- Bladder Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Multi4 Medical AbIndustry (pharma, biotech, devices)
- Collaborators
- Key2Compliance
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 2 Apr 2025 (actual)
- Study completion
- 2 Apr 2025 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Clinical Investigation to Confirm Performance and Safety of the Multi4 System in Patients with Suspected Recurrent Bladder Cancer Lesions
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multi4 procedure | Experimental | Device: Multi4Complete TURBT procedure performed in local anesthesia with Multi4 instrument via flexible cystoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi4TURBT procedure performed with the Multi4 instrument in local anesthesia | Device | Multi4 procedure |
Primary outcome
Evaluable biopsies
Time frame: At procedure
Biopsies collected by the instrument are evaluable by pathologist
9 secondary outcomes
Number of participants with treatment-related adverse events
Time frame: One week
Number of patients with complete procedures performed
Time frame: At procedure
Patient-reported treatment-related pain (numeric rating scale)
Time frame: At procedure
Quality of life (EQ-5D-5L)
Time frame: At procedure and after 1 week
Time to perform procedure
Time frame: At procedure
Time for patient surveillance
Time frame: At procedure
Self reported satisfaction with procedure
Time frame: One week
Operator-reported ease of use
Time frame: At procedure
Cost effectiveness
Time frame: At procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik Kjölhede, MD PhD principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi4 in people with Bladder Cancer, run by Multi4 Medical Ab at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluable biopsies (time frame: At procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.