IlluminOss Hand Fracture International Clinical Feasibility Study
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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: NCT00823251 |
Recruitment Status
:
Completed
First Posted
: January 15, 2009
Last Update Posted
: June 7, 2017
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Sponsor:
IlluminOss Medical, Inc.
Information provided by (Responsible Party):
IlluminOss Medical, Inc.
Tracking Information | |||||
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First Submitted Date ICMJE | December 30, 2008 | ||||
First Posted Date ICMJE | January 15, 2009 | ||||
Last Update Posted Date | June 7, 2017 | ||||
Study Start Date ICMJE | December 2008 | ||||
Actual Primary Completion Date | October 2009 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Technical Success: Successful implantation of an IlluminOss bone-pin via percutaneous techniques at the target fracture location. [ Time Frame: Immediately post-surgery ] | ||||
Original Primary Outcome Measures ICMJE | Not Provided | ||||
Change History | Complete list of historical versions of study NCT00823251 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Outcome Measures ICMJE | Not Provided | ||||
Original Other Outcome Measures ICMJE | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | IlluminOss Hand Fracture International Clinical Feasibility Study | ||||
Official Title ICMJE | IlluminOss Medical- Photodynamic Bone Stabilization System- International Study | ||||
Brief Summary | The purpose of this study is to assess the initial safety and technical feasibility of the IlluminOss System in the treatment of fractures of bones in the hand. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 | ||||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Orthopedic Fractures | ||||
Intervention ICMJE | Device: IlluminOss device
The IlluminOss™ Bone Stabilization System is designed to deliver the device to the fracture site via the medullary canal of the bone using percutaneous techniques. Once the device is in place and has spanned the fracture site, the device is expanded and hardened to reduce and stabilize the fracture, to aid in the support and healing of the bone fracture by primary callous formation and remodeling. |
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Study Arms | Experimental: IlluminOss device
IlluminOss bone-pin device
Intervention: Device: IlluminOss device |
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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 | Completed | ||||
Actual Enrollment ICMJE |
4 | ||||
Original Enrollment ICMJE | Not Provided | ||||
Actual Study Completion Date | February 2013 | ||||
Actual Primary Completion Date | October 2009 (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 to 80 Years (Adult, Senior) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Chile | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT00823251 | ||||
Other Study ID Numbers ICMJE | ILLUM-OUS-2008-001 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||
Responsible Party | IlluminOss Medical, Inc. | ||||
Study Sponsor ICMJE | IlluminOss Medical, Inc. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | IlluminOss Medical, Inc. | ||||
Verification Date | June 2017 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |