Status:
COMPLETED
To Evaluate the Feasibility, Preliminary Safety and Performance of Rezūm System in BPH Treatment in China
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Benign Prostatic Hyperplasia (BPH)
Eligibility:
MALE
50+ years
Brief Summary
A real world study to evaluate the feasibility, preliminary safety and performance of Rezūm system in BPH treatment in China Rezūm RWS study
Detailed Description
This RWS study is to evaluate the feasibility, preliminary safety and performance of Rezūm system in BPH treatment in China, to generate local real world data from a Chinese BPH population. The Rezūm...
Eligibility Criteria
Inclusion
- The subjects will provide written informed consent form and agree to data collection.
- The subjects who were diagnosed as BPH and treated by Rezūm procedure in Hainan medical pilot zone will be enrolled in this study.
Exclusion
- This is a retrospective study without any formal exclusion criteria.
Key Trial Info
Start Date :
July 10 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2021
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04823221
Start Date
July 10 2021
End Date
August 1 2021
Last Update
March 2 2022
Active Locations (1)
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1
Boao Yiling Life Care Center
Boao, Hainan, China, 571437