An observational study in Perfusion; Complications, sponsored by Christie Medical Holdings, Inc.. Terminated at 1 site in United States. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-10.
Sponsored by Christie Medical Holdings, Inc. · Observational
This study is designed to evaluate the information provided to the clinicians by the surgical imaging device. It is also to gain insight on the user interface and how "user friendly" it is to the clinician.
Over the last decade, objective ways of measuring tissue oxygen have been introduced into the medical arena and are being used more and more for assessing ischemic events in tissue. Handheld Doppler ultrasound, infrared thermography, polarized spectral imaging, laser Doppler perfusion imaging, and fluorescence imaging have all been used with some degree of success. However, only a few have gained universal acceptance. [1] Multispectral imaging (MSI) which uses near-infrared (NIR) light to measure tissue oxygen levels in superficial tissue is another method that has been successfully used to assess tissue flap health.
The objective of this study is to conduct an evaluation of superficial tissue with Presygen™/si-1 in various patient types for surgical imaging during breast reconstruction. In addition, participating surgeons will complete a structured survey regarding their assessment of Presygen™/si-1 work station during the surgical procedure.
Primary Goal: Evaluation of superficial tissue in various patient types for surgical imaging during breast reconstruction.
Secondary Goal: Surgeon assessment of surgical work station during surgery through a prepared questionnaire.
Christie Medical Holdings, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients undergoing breast reconstruction surgery and meet the inclusion and exclusion criteria.
Exclusion Criteria:
Patients will be imaged with imaging device (Presygen™/si-1) during surgical procedure. Image surgical area. Surgical procedure will follow standard of care. No clinical decisions will be made on device readings. A surgeon will complete a survey regarding his assessment of the imaging device.
Device: Image surgical area
Image surgical area
Also known as: Questionnaire on ease of use and general opinion
Photographic, electronic and descriptive comparative analysis of superficial tissue oxygen saturation using Presygen™/si-1 for breast reconstruction subjects.
Quantitative measures of tissue oxygen saturation for discrete locations on superficial tissue.
Time frame: 24 hours.
Quantitative survey providing surgeon assessment of work station during procedure.
completion of basic questionnaire
Time frame: 24 hours
Plan to share: Undecided
This study is terminated, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Christie Medical Holdings, Inc.