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A Pilot Study to Evaluate Multi-Spectral Imaging and Laser Speckle Imaging During Vascular Occlusion

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01484730
First received: November 29, 2011
Last updated: October 28, 2014
Last verified: October 2014
  Purpose

The purpose of this research is to evaluate and validate the performance of non-invasive imaging modalities for assessment of skin. A pressure cuff occlusion will be used to stimulate blood flow dynamic that these instruments are designed to sense. The researcher currently plan to assess only basic feasibility of the imaging instruments.


Condition Intervention
Abnormal Vascular Flow
Device: Multi-Spectral & Laser Speckle Imaging

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: A Pilot Study to Evaluate Multi-Spectral Imaging and Laser Speckle Imaging During Vascular Occlusion

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Skin blood flow [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: November 2011
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Vascular Occulsion
Multi-Spectral & Laser Speckle Imaging
Device: Multi-Spectral & Laser Speckle Imaging
Changes in skin tissue and blood flow.
Other Name: Multi-Spectral & Laser Speckle Imaging

Detailed Description:

The primary reason for including pressure cuff occlusion in this protocol is to test the performance of Multi-Spectral Imaging and Laser Speckle Imaging can measure in the full range of vascular conditions ranging from ischemic (under-perfused or unsaturated) to hyperemic (over-perfused and over-saturated).

  1. .Modulated Imaging a non-contact optical imaging technology can detect the concentration of total hemoglobin, deoxygenated and oxygenated hemoglobin in absolute amounts in units of millimoles / unit volume of tissue measured.
  2. . Laser Speckle Imaging a non-contact optical imaging technology consists of a coherent light source, camera, and image acquisition system. This image device can measure and compare relative flow in vasculature at varied time points.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Study population will be selected from University of California Irvine, student and staff member.

Criteria

Inclusion Criteria:

  • Male and female adult 18 years and older

Exclusion Criteria:

  • Younger than 18 years of age
  • Pregnant women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01484730

Locations
United States, California
Beckman Laser Institute, UCI
Irvine, California, United States, 92612
Sponsors and Collaborators
Montana Compton
Investigators
Principal Investigator: Anthony Durkin, PhD Beckman Laser Institute, UCI
  More Information

No publications provided

Responsible Party: Montana Compton, Administrative Nurse Research Coordinator, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01484730     History of Changes
Other Study ID Numbers: NIH/LAMMP-2011-8370
Study First Received: November 29, 2011
Last Updated: October 28, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 20, 2014