Trials / Completed
CompletedNCT06136312
Clinical Investigation of the Multi4 System
A Clinical Investigation to Confirm Performance and Safety of the Multi4 System in Patients With Suspected Recurrent Bladder Cancer Lesions
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Multi4 Medical Ab · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Multi4 | TURBT procedure performed with the Multi4 instrument in local anesthesia |
Timeline
- Start date
- 2023-12-01
- Primary completion
- 2025-04-02
- Completion
- 2025-04-02
- First posted
- 2023-11-18
- Last updated
- 2025-04-09
Locations
1 site across 1 country: Sweden
Source: ClinicalTrials.gov record NCT06136312. Inclusion in this directory is not an endorsement.