Protection of Rectum From High Radiation Doses
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|ClinicalTrials.gov Identifier: NCT01601691|
Recruitment Status : Completed
First Posted : May 18, 2012
Results First Posted : November 14, 2014
Last Update Posted : November 14, 2014
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Device: DuraSeal||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Protection of Rectum From High Radiation Doses|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||March 2013|
Subjects with spacer injection
Single dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate
- Spacer Volume Half Life [ Time Frame: 1 day, 4 weeks, 8 weeks, up-to 16 weeks ]Time to spacer resolution will be measured based on the distance between rectum wall and prostate on CT scans before operation and on defined time frame. In addition, magnetic resonance imaging of pelvis will be performed 8 to 16 weeks after the operation in order to confirm the extent of spacer. Spacer volume half life is reported.
- Side Effects [ Time Frame: 1 day, 4 weeks, 8 weeks, 12 weeks ]Possible side effects will be collected by subject interview and physical examination on specified time frame.
- Rectum Radiation Dose [ Time Frame: 1 day, 4 weeks, 8 weeks ]Rectum dose will be calculated based on CT scans after brachytherapy.
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): NCT01601691
|Oulu University Hospital|
|Oulu, Finland, 90029|
|Principal Investigator:||Markku Vaarala, MD, PhD||Oulu Univeristy Hospital|
|Study Chair:||Merja Korpela, MD||Oulu University Hospital|
|Study Chair:||Vesa-Pekka Heikkilä, FL||Oulu University Hospital|