Evaluate Ease of Use and Surgeons Opinions of Presygen™/Si-1 (Presygen™)
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|ClinicalTrials.gov Identifier: NCT03715270|
Recruitment Status : Not yet recruiting
First Posted : October 23, 2018
Last Update Posted : October 24, 2018
|Condition or disease||Intervention/treatment|
|Perfusion; Complications||Device: Image surgical area|
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.  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.
|Study Type :||Observational|
|Estimated Enrollment :||25 participants|
|Official Title:||Prospective Non-randomized, Non-blinded, Convenience Sample to Evaluate the Surgical Imaging System|
|Estimated Study Start Date :||November 2018|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2019|
breast reconstruction surgery patients
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
Other Name: 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. [ Time Frame: 24 hours. ]Quantitative measures of tissue oxygen saturation for discrete locations on superficial tissue.
- Quantitative survey providing surgeon assessment of work station during procedure. [ Time Frame: 24 hours ]completion of basic questionnaire
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): NCT03715270
|Contact: Eileen C Lane, MBAfirstname.lastname@example.org|
|Contact: Bruce D Cusson, RNemail@example.com|
|United States, New Jersey|
|Englewood Hospital and Medical Cetner|
|Englewood, New Jersey, United States, 07631|