Status:
COMPLETED
SpaceOAR System RWS in China
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Localized T1-T2 Prostate Cancer
Eligibility:
All Genders
Phase:
NA
Brief Summary
This study aims to evaluate the safety and performance of SpaceOAR System when it is used to create space between the rectum and prostate in men undergoing radiotherapy for localized T1-T2 prostate ca...
Detailed Description
This study is a retrospective and prospective, single arm, real world study. For those patients who have already received the SpaceOAR treatment before study kick-off, the data at baseline and the day...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Subjects has provided the written informed consent, willing to participate in clinical data collection and willing to receive visit at 30 days post procedure. (for subjects enrolled prospectively)
- Subjects must have been pathologically confirmed prostate cancer with clinical stage T1-T2, and have been treated or will be treated with Space OAR Hydrogel in hospital in Hainan Boao Lecheng medical pilot zone.
- Exclusion Criteria- no specific exclusion criteria unless the patients refuse to sign the informed consent.
Exclusion
Key Trial Info
Start Date :
August 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 6 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05407714
Start Date
August 18 2022
End Date
July 6 2023
Last Update
October 27 2025
Active Locations (1)
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1
Boao First Life Care Center-Hospital
Qionghai, Hainan, China, 571434