Status:
COMPLETED
Clinical Investigation of the Multi4 System
Lead Sponsor:
Multi4 Medical Ab
Collaborating Sponsors:
Key2Compliance
Conditions:
Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2025
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06136312
Start Date
December 1 2023
End Date
April 2 2025
Last Update
April 9 2025
Active Locations (1)
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1
Sahlgrenska University Hospital
Gothenburg, Sweden