Post-marketing Surveillance Regarding Efficacy and Safety of SpaceOAR™
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01999660|
Recruitment Status : Unknown
Verified November 2013 by CS Diagnostics GmbH.
Recruitment status was: Recruiting
First Posted : December 3, 2013
Last Update Posted : February 25, 2015
|Condition or disease||Intervention/treatment|
|Prostate Cancer Patients Treated by Radiotherapy||Device: SpaceOAR™ implantation|
|Study Type :||Observational|
|Estimated Enrollment :||250 participants|
|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|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||January 2016|
|Estimated Study Completion Date :||January 2019|
prostate cancer patient prophetically treated by SpaceOAR™
Device: SpaceOAR™ implantation
- the rectal complication rate (late toxicity) [ Time Frame: 6 months and yearly for 5 years thereafter ]the rectal complication rate following the common toxicity criteria (CTC) v. 2.0
- Quality of Life [ Time Frame: 6 months and for 5 years yearly thereafter ]The validated Expanded Prostate Cancer Index Composite (EPIC) questionnaire in combination with the validated Short Form Health Survey (SF-12) will be used to document the influence on the quality of life (QoL).
- feasibility of the implantation procedure [ Time Frame: 1 day ]feasibility of the implantation procedure will be documented by subjective description given by the investigators. this includes safety aspects.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01999660
|Contact: Eike G. Fischer, Dr.||+49 241 4500 email@example.com|
|Clinic for Radiooncology and Radiotherapy, Evangelical Clinics Gelsenkirchen||Recruiting|
|Gelsenkirchen, NRW, Germany, 45879|
|Contact: Razvan Galalae, PD Dr. med. +49 209 - 160 - 53001 firstname.lastname@example.org|
|Principal Investigator: Razvan Galalae, PD Dr. med.|
|Principal Investigator:||Razvan Galalae, PD Dr. med.||Clinic for Radiooncology and Radiotherapy, Evangelical Clinics Gelsenkirchen, Germany|