Prospective Non-randomized, Non-blinded, Convenience Sample to Evaluate the Surgical Imaging System
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Photographic, electronic and descriptive comparative analysis of superficial tissue oxygen saturation using Presygen™/si-1 for breast reconstruction subjects.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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)
结局指标
主要结局
Photographic, electronic and descriptive comparative analysis of superficial tissue oxygen saturation using Presygen™/si-1 for breast reconstruction subjects.
时间窗: 24 hours.
Quantitative measures of tissue oxygen saturation for discrete locations on superficial tissue.
次要结局
- Quantitative survey providing surgeon assessment of work station during procedure.(24 hours)