Trials / Terminated
TerminatedNCT01999660
Post-marketing Surveillance Regarding Efficacy and Safety of SpaceOAR™
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 119 (actual)
- Sponsor
- CS Diagnostics GmbH · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SpaceOAR™ implantation |
Timeline
- Start date
- 2013-11-01
- Primary completion
- 2019-08-01
- Completion
- 2019-08-01
- First posted
- 2013-12-03
- Last updated
- 2021-07-27
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT01999660. Inclusion in this directory is not an endorsement.