The Implantation Under Echography of Fiducial Markers in the Intraprostatic Lesion and Prostate
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ClinicalTrials.gov Identifier: NCT00841685 |
Recruitment Status
: Unknown
Verified December 2014 by University Hospital, Ghent.
Recruitment status was: Recruiting
First Posted
: February 11, 2009
Last Update Posted
: December 5, 2014
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Sponsor:
University Hospital, Ghent
Collaborators:
IBA, Germany
Hospimed, Netherland
Bard Ltd
Information provided by (Responsible Party):
University Hospital, Ghent
Tracking Information | ||||
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First Submitted Date ICMJE | February 10, 2009 | |||
First Posted Date ICMJE | February 11, 2009 | |||
Last Update Posted Date | December 5, 2014 | |||
Study Start Date ICMJE | December 2008 | |||
Estimated Primary Completion Date | May 2015 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Acute toxicity after implantation of the fiducial gold markers [ Time Frame: 1 week after implantation ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT00841685 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | The Implantation Under Echography of Fiducial Markers in the Intraprostatic Lesion and Prostate | |||
Official Title ICMJE | The Implantation Under Echography of Fiducial Markers in the Intraprostatic Lesion and Prostate | |||
Brief Summary | Implantation of fiducial markers in the prostate and daily check of the positioning during radiotherapy based on the implanted fiducial markers | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) |
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Condition ICMJE | Prostate Cancer | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE |
20 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date | May 2015 | |||
Estimated Primary Completion Date | May 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Belgium | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00841685 | |||
Other Study ID Numbers ICMJE | 2008/109 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | University Hospital, Ghent | |||
Study Sponsor ICMJE | University Hospital, Ghent | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University Hospital, Ghent | |||
Verification Date | December 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |