Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06338436
Status:
COMPLETED
Last Update Posted:
2024-04-02
First Post:
2024-03-22
Brief Title:
Varian ProBeam Proton Therapy System China Clinical Trial Guangzhou
Sponsor:
Varian a Siemens Healthineers Company
Organization:
Varian a Siemens Healthineers Company
Study Overview
Official Title:
Varian ProBeam Proton Therapy System China Clinical Trial Guangzhou
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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
And long-term follow-up report will be submitted for future post market evaluation when requested by NMPA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None