47
Participants
Start Date
July 20, 2022
Primary Completion Date
March 8, 2023
Study Completion Date
March 10, 2023
Radiation: Proton Therapy System (ProBeam)
"All enrolled subjects will be treated with Proton radiation therapy using the medical device Varian Proton Therapy System (ProBeam). The screening period from informed consent to enrollment is expected to be 2 weeks, while the treatment period depends on patient medical situation and treatment plan. The period after the last treatment is divided into short-term follow-up which is 90 days after treatment completion and long-term follow-up which is 5 years after treatment completion. The clinical trial with short-term follow-up fulfills the requirements for NMPA regulatory registration. All the end points claimed will be achieved in the short-term follow-up stage. The trial is defined as completion once short-term follow-up is finished.~And long-term follow-up report will be submitted for future post market evaluation when requested by NMPA."
Sophia Shao, Shanghai
Varian, a Siemens Healthineers Company
INDUSTRY