Prospective Non-randomized, Non-blinded, Convenience Sample to Evaluate the Surgical Imaging System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Photographic, electronic and descriptive comparative analysis of superficial tissue oxygen saturation using Presygen™/si-1 for breast reconstruction subjects.
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Candidate for surgical intervention with breast reconstruction as part of the surgical plan
- •22 years of age or older;
- •Able to understand and provide informed consent with HIPAA authorization.
- •Able to read and understand in English.
Exclusion Criteria
- •Subjects who might need a legally-authorized representative
- •Subjects who possess diminished mental capabilities
- •Conditions that preclude imaging (excessive scarring, tattoos in surgical field, Fitzpatrick Scale VI)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Quantitative survey providing surgeon assessment of work station during procedure.(24 hours)