What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are En-Bloc Resection of Bladder Tumours. The registry lists allocation as na. This is a prospective, single-arm study to measure the feasibility and safety of performing transurethral en-bloc resection of bladder tumours using the Zenith robotic system.
They plan to enroll about 10 people at Shatin. Taking part typically means a procedure as part of the study plus check-ins.
Official title (unrewritten)
First-in-Human Trial of a Novel Endoluminal Robotic System for En-Bloc Resection of Bladder Tumours
Interventions: En-Bloc Resection of Bladder Tumours
Primary outcome (registry wording): Successful en-bloc tumour resection by the robotic system