Evaluating Impact of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Average Number of Parathyroid Glands Identified
研究概览
简要总结
This study will see if the use of near infrared autofluorescence (NIRAF) detection with an FDA-cleared device 'Parathyroid Eye (PTeye)' for identifying parathyroid glands (PGs) during parathyroidectomy (PTx) procedures is better than a surgeon's detection alone. It compares risk-benefits and outcomes in PTx patients where NIRAF detection with PTeye for parathyroid identification is either used or not used.
Parathyroidectomy - look at application of the technology to see if it assists during a parathyroidectomy.
详细描述
Prior to data collection, it was determined some additional outcome measures collected by the primary site would not be relevant to the trial for participating sites such as this site. Those outcomes were removed from this record.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Only participants will be masked to the intervention
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary hyperparathyroidism who will be undergoing parathyroid surgery
- •Persistent primary hyperparathyroidism after having undergone a failed prior parathyroid surgery who will be undergoing repeat parathyroid surgery
排除标准
- •Pregnant women (Those patients who could potentially will receive preoperative pregnancy testing, as is standard before general anesthesia. Any patients with positive pregnancy test results will not be included in the study.)
- •Patients with concurrent parathyroid and thyroid disease that require total thyroidectomy
- •Patients with secondary or tertiary hyperparathyroidism
结局指标
主要结局
Average Number of Parathyroid Glands Identified
时间窗: Measured within the procedure, generally not more than 2 hours
Average number of parathyroid glands identified between the Experimental Group: Glands identified with naked eye + NIRAF vs. the Control Group: Glands identified with naked eye.
次要结局
- Parathyroid Hormone (PTH) Levels 5-14 Days After Surgery(5-14 days after surgery)
- Appropriate Intraoperative Parathyroid Hormone Drop(baseline to 10 minutes)
- Parathyroid Hormone (PTH) Levels 5-14 Days After Surgery(5-14 days after surgery)
- Appropriate Intraoperative Parathyroid Hormone Drop(baseline to 10 minutes)
- Duration of Surgery(Measured within the procedure, generally not more than 2 hours)
- Number of Nights Spent in the Hospital After Parathyroidectomy(0-72 hours after PTx procedure.)
- Number of Frozen Sections(Immediate)
研究者
Paul Gauger
Ambulatory Care Clinical Chief, William J Fry Professor of Surgery and Professor of Surgery, Medical School
University of Michigan