Not provided
Not provided
Not provided
Not provided
Not provided
Sponsor decision to end study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 Presygenâ„¢/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 Presygenâ„¢/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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| breast reconstruction surgery patients | Patients will be imaged with imaging device (Presygenâ„¢/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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Image surgical area | Device | Image surgical area |
|
| Measure | Description | Time Frame |
|---|---|---|
| Photographic, electronic and descriptive comparative analysis of superficial tissue oxygen saturation using Presygenâ„¢/si-1 for breast reconstruction subjects. | Quantitative measures of tissue oxygen saturation for discrete locations on superficial tissue. | 24 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative survey providing surgeon assessment of work station during procedure. | completion of basic questionnaire | 24 hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients undergoing breast reconstruction surgery and meet the inclusion and exclusion criteria.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Englewood Hospital and Medical Cetner | Englewood | New Jersey | 07631 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19337092 | Result | Pestana IA, Coan B, Erdmann D, Marcus J, Levin LS, Zenn MR. Early experience with fluorescent angiography in free-tissue transfer reconstruction. Plast Reconstr Surg. 2009 Apr;123(4):1239-1244. doi: 10.1097/PRS.0b013e31819e67c1. | |
| 21620154 | Result | Colwell AS, Craft RO. Near-infrared spectroscopy in autologous breast reconstruction. Clin Plast Surg. 2011 Apr;38(2):301-7. doi: 10.1016/j.cps.2011.03.014. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided