The Development of a Surgical Localizing Aid Medical Device and the Determination and Analysis of Significant Variables
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Incision Length
研究概览
简要总结
The current method of incision localization in many surgical procedures requires a doctor to reference a medical image, such as an X-ray, to judge where on the body an incision should be made. However, the precise information of the scan is not shown on the patient's skin. Surgeons commonly use palpation to locate the point of incision. They may feel for the area directly or find landmarks under the skin and estimate the location from there. The following factors further complicate palpation: overweight patients, foreign bodies that are difficult to feel for under the skin, fractures with little displacement, or locations under dense muscles. These difficulties are compounded for new surgeons, since palpation is a skill derived through experience.
In many circumstances the surgeon only needs to know where to insert the tool or place the incision - they do not necessarily need to know the depth of the area of interest. If palpation proves ineffective, they may be forced to use fluoroscopy. By referencing the fluoroscopy image the surgeon moves a radiopaque marker, such as their surgical tool, closer to the area of interest. Fluoroscopy is time-consuming, and exposes medical personnel and the patient to radiation. Many fluoroscopic images may be required in a single procedure.
By identifying the efficacy of this new medical device, "Target Tape", there is the potential outcome of making smaller incisions, faster localization, a reduction in fluoroscopy use and a reduced chance in surgical error and the associated costs.
Target Tape is a non invasive device that is in a grid or ruler format that is placed against the subject's skin. The grid/ruler pattern will then appear on the medical imaging scan. Standard surgical skin ink is then used to place these markings in a defined pattern on the skin. This pattern mimics the Target Tape grid or ruler pattern. The medical practitioner can correlate these skin markings to the medical scan image to make their incisions in more accurate locations.
详细描述
Consent must first be obtained from the prospective patient before Target Tape can be incorporated into the procedure. When a target procedure is scheduled to occur, the surgeon will first determine if Target Tape would be appropriate to use. The procedure will need to be able to integrate Target Tape into it using the Method of Use described above. The decision to then pursue the procedure will be under the discretion of the medical practitioner and consent from the patient. Depending on the procedure, the medical practitioner may need to communicate to the OR or the radiology department to integrate Target Tape into their protocol, since the practitioner making the incisions(s) may not always be the one applying it. Examples of procedures that may utilize Target Tape may be stabilization of fractures, interlocking screw insertions during tibia or femur nailings, breast biopsies, foreign body removals, thoracic and spinal surgeries. Once the procedure is determined to be appropriate to accommodate Target Tape, the medical practitioner will approach the prospective patient and explain how the device will be utilized, the benefits and potential risks associated with it, and answer any questions the patient may have. A representative from Aeos Biomedical may be on hand to aid with this process and may also observe said procedure to record the necessary information. The consent form will then be signed and Target Tape will then be utilized during the procedure.
The methodology of creating an outcome measure will occur over 2 stages with multiple steps in each stage:
Stage I: Proof of Concept
- Specify measurement goals
- Proof of Concept Testing
- Item generation
- Item reduction
Stage 2: Verification 5. Verification Testing 6. Reliability 7. Validity 8. Interpretability
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must be undergoing a radiological imaging, such as planar X-ray, fluoroscopy, CT or MRI
排除标准
- •Subjects who may have allergies to medical skin adhesives, medical skin inks or copper metal
结局指标
主要结局
Incision Length
时间窗: one year
Measuring the reduction in incision length from using Target Tape
次要结局
- Reduction in Fluoroscopy Exposure(one year)
- Procedure Time Savings(One Year)