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Trial Title:
Clinical Investigation of the Multi4 System
NCT ID:
NCT06136312
Condition:
Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Multi4
Description:
TURBT procedure performed with the Multi4 instrument in local anesthesia
Arm group label:
Multi4 procedure
Summary:
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
December 1, 2023
Completion date:
September 30, 2024
Lead sponsor:
Agency:
Multi4 Medical Ab
Agency class:
Industry
Collaborator:
Agency:
Key2Compliance
Agency class:
Other
Source:
Multi4 Medical Ab
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06136312
