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SpaceOAR System RWS in China

NCT05407714 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-10-27

Study results available
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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 cancer in China via collecting the real word data of SpaceOAR System used, to generate local clinical evidence on Chinese patients.

Conditions

  • Localized T1-T2 Prostate Cancer

Interventions

DEVICE

SpaceOAR Treatment

SpaceOAR System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceOAR System to reduce the radiation dose delivered to the anterior rectum. The SpaceOAR System is composed of biodegradable material and maintains space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Sujun Han · Boao Yiling Life Care Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-18
Primary Completion
2023-06-12
Completion
2023-07-06
FDA Device
Yes

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05407714 on ClinicalTrials.gov