Varian ProBeam Proton Therapy System Clinical Trial (Shandong)

Tumor, Solid Clinical Trial

Official title: Varian ProBeam Proton Therapy System Clinical Trial (Shandong)

Status Completed

Clinical Trial Summary

This study is prospective, single-center, single-arm objective performance criteria.

This trial will be conducted with a total of 47 subjects enrolled. All of subjects will be treated with radiation therapy using the medical device Varian ProBeam Proton Therapy System (ProBeam), aim to compare the data with objective performance criteria (OPC) to evaluate the effectiveness and safety of ProBeam radiotherapy system for oncology patients, providing a clinical basis for the medical device registration.

Clinical Trial Description

Oncology patients, including tumors of head and neck, chest, abdomen, spine, pelvic cavity, extremities and other tumors. 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 National Medical Products Administration (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. ;

Related Conditions & MeSH terms

• Tumor, Solid

• NCT number: NCT06340815
• Study type: Interventional
• Source: Varian, a Siemens Healthineers Company
• Status: Completed
• Phase: N/A
• Start date: July 20, 2022
• Completion date: March 10, 2023