Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 7:14 PM
Study NCT ID:
NCT01999660
Status:
TERMINATED
Last Update Posted:
2021-07-27
First Post:
2013-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-marketing Surveillance Regarding Efficacy and Safety of SpaceOAR™
Sponsor:
CS Diagnostics GmbH
Organization:
Study Overview
Official Title:
Prospective National Post-marketing Surveillance for the Investigation of the Efficacy and Safety of SpaceOAR™ to Maintain Space Between the Rectum and Prostate During Radiation Therapy
Status:
TERMINATED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI did leave hospital (retired)
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A treatment with SpaceOAR™ hydrogel does reduce late toxicity Grad 2 and Grad 3 of radiation therapy in prostate cancer patients
Detailed Description:
The degradable SpaceOAR™ hydrogel establishes for the time of radiotherapy a distance between the prostate and the rectum
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: