SPY Angiography To Determine the Extent of Nerve Release After Nerve Decompression
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in level of Fluorescence before and after nerve release.
研究概览
简要总结
Patients with vascular disease, thyroid disease or an allergy to indocyanine green (ICG) will be excluded. Patients with either median or ulnar nerve compression will be treated with nerve decompression. SPY angiography will be used to assess the vascularity of the nerve both pre and post release as the primary outcome measure.
详细描述
The purpose of this study is to use laser imaging to determine the extent of nerve decompression (release) while patients are still in surgery. Commonly, this is determined by electrodiagnostic tests or physical examination. The researchers will use the SPY elite device along with an injection of a drug called SPY Agent green (indocyanine green) in an imaging procedure called fluorescence angiography to visualize the change in blood supply to the nerve, following the nerve decompression surgery and assess if SPY is a useful tool for evaluating the success of nerve decompression surgery. The use of fluorescence angiography with the SPY elite device and SPY agent green is Food and Drug Administration (FDA) approved.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old or older; male and female patients
- •Ulnar Nerve Compression at the Elbow
- •Failed conservative treatment (i.e. hand therapy, pain medications, splinting)
- •Able to provide informed consent
排除标准
- •Pregnancy/breastfeeding
- •Thyroid Disease
- •Vascular Disease
- •Known allergy to any study drug
研究组 & 干预措施
Study Group
Participants will have planned surgical procedure to repair the median or ulnar nerve compression. During the procedure, the doctor will administer a small injection of indocyanine green (ICG) and laser angiography using the SPY Elite device will be used to evaluate blood flow and extent of nerve decompression at the surgical site. Participation will also involve filling out two questionnaires on pain and function level and an examination of hand strength and range of motion.
干预措施: Indocyanine green (Drug)
结局指标
主要结局
Change in level of Fluorescence before and after nerve release.
时间窗: 2 weeks, 6 weeks, 3 months, 6 months, and 12 months visits
Assessed by comparing the SPY angiography value before and after nerve release surgery
次要结局
- nerve function determined by grip strength(2 weeks, 6 weeks, 3 months, 6 months, and 12 months visits)
- Change in Monofilament sensory testing(2 weeks, 6 weeks, 3 months, 6 months, and 12 months visits)
- Change in DASH Score(2 weeks, 6 weeks, 3 months, 6 months, and 12 months visits)