Study on the Safety and Effectiveness of Varian ProBeam Proton Therapy Equipment in the Treatment of Solid Tumors
NCT05914142 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47
Last updated 2023-11-07
Summary
This study is a clinical trial of prospective, single-arm objective performance criteria. This trial will be conducted in clinical trial sites 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.
Conditions
- Solid Tumor
- Radiation Therapy
- Proton Therapy
Interventions
- DEVICE
-
Proton radiation therapy
Radiation: Proton Therapy System (ProBeam)
Sponsors & Collaborators
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
collaborator OTHER -
Varian, a Siemens Healthineers Company
collaborator INDUSTRY -
Guangzhou Concord Cancer Center
lead OTHER
Principal Investigators
-
Yimin Liu, Professor · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
-
Shen Fu, Professor · Guangzhou Concord Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-12-15
- Primary Completion
- 2023-07-04
- Completion
- 2023-07-04
Countries
- China
Study Locations
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