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Brief Title: Clinical Investigation of the Multi4 System
Official Title: A Clinical Investigation to Confirm Performance and Safety of the Multi4 System in Patients With Suspected Recurrent Bladder Cancer Lesions
Study ID: NCT06136312
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 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Name: Henrik Kjölhede, MD PhD
Affiliation: Sahlgrenska University Hospital, Sweden
Role: PRINCIPAL_INVESTIGATOR