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Hyperspectral Imaging Pre and Post Endovascular Intervention (CLI-Pre/Post)

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: NCT00768495
Recruitment Status : Unknown
Verified June 2009 by HyperMed.
Recruitment status was:  Recruiting
First Posted : October 8, 2008
Last Update Posted : June 4, 2009
Sponsor:
Collaborator:
Cardiac, Vascular & Thoracic Surgery Associates, P.C. (CVTSA)
Information provided by:
HyperMed

Tracking Information
First Submitted Date October 6, 2008
First Posted Date October 8, 2008
Last Update Posted Date June 4, 2009
Study Start Date October 2008
Estimated Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Hyperspectral Imaging Pre and Post Endovascular Intervention
Official Title Evaluation of the Success of Endovascular Peripheral Revascularization for the Treatment of Chronic Limb Ischemia by Measuring OxyHb and DeoxyHb Using a New Hyperspectral Imaging Device (OxyVu).
Brief Summary This trial will collect tissue oxygenation data via hyperspectral imaging before and after endovascular procedures.
Detailed Description This will be a nonrandomized, nonblinded, prospective observational study to correlate the results obtained with the traditional measures of success of endovascular revascularization of peripheral arteries for the treatment of chronic limb ischemia; i.e., ABPI, PVR with oxyhemoglobin (OxyHb) and deoxyhemoglobin (DeoxyHb) measurements obtained with a new imaging device manufactured by HyperMed Inc (OxyVu) that uses hyperspectral technology.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients who have chronic limb ischemia and present with the symptoms of claudication, rest pain or having minor non-healing ulcers or gangrene (Rutherford category 1 to 6) who also require percutaneous endovascular revascularization.
Condition
  • Chronic Limb Ischemia
  • Non-Healing Ulcers
Intervention Not Provided
Study Groups/Cohorts One Cohort
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: October¬†7,¬†2008)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2009
Estimated Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Patients with established diagnosis of lower limb ischemic based on their symptoms of claudication, rest pain, non-healing ulcers or gangrene and other vascular laboratory tests that are currently used to make this diagnosis and have been scheduled for endovascular revascularization.
  2. Age group between 50-85
  3. Gender - Male or Female
  4. Race - all race and ethnicities

Exclusion Criteria:

  1. Patients with known cardiac disease - new MI (within 3 months).
  2. Patients with hypertension with the systolic BP >200 or diastolic BP>110 on the day of testing
  3. Patients on supplemental O2 for chronic obstructive lung disease
  4. Bed-ridden subjects - either due to chronic disability or neurological problems
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00768495
Other Study ID Numbers 2008-023
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Kevin Schomacker, HyperMed, Inc.
Study Sponsor HyperMed
Collaborators Cardiac, Vascular & Thoracic Surgery Associates, P.C. (CVTSA)
Investigators
Study Director: Kevin Schomacker, PhD HyperMed
PRS Account HyperMed
Verification Date June 2009