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
- 79
- 试验地点
- 1
- 主要终点
- Median Number of Frozen Sections (or Parathyroid Aspirate) Sent for Analysis
研究概览
简要总结
The goal of this study is to assess whether using PTeye (AiBiomed, Santa Barbara, CA) - a NIRAF detection modality - can improve patient outcomes and reduce healthcare associated costs after parathyroid surgeries. By being able to quickly and definitively locate parathyroid glands while in the operating room, the duration of surgical procedure could be further reduced. In addition, the number of frozen section biopsy and associated costs can be minimized. Furthermore, repeat surgeries as a result of missing a diseased parathyroid gland at the time of the initial parathyroidectomy for hyperparathyroidism could potentially be avoided.
详细描述
This is a prospective, single-blinded, randomized study comparing the use of PTeye during parathyroidectomy to usual standard practice.
PRIMARY OBJECTIVES:
I. Assess the impact of PTeye on intra-operative identification of parathyroid tissues.
II. Assess the impact of PTeye on improving efficiency of parathyroid surgeries.
III. Assess the impact of PTeye on minimizing risk of post-surgical complications.
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
- •All adults >=18 years old) patients with primary hyperparathyroidism who will be undergoing parathyroid surgery
- •All adult (>=18 years old) patients with persistent primary hyperparathyroidism after having undergone a failed prior parathyroid surgery who will be undergoing repeat parathyroid surgery
排除标准
- •Children and minors
- •Pregnant women
- •Patients with concurrent parathyroid and thyroid disease that require total thyroidectomy
- •Patients with secondary or tertiary hyperparathyroidism
研究组 & 干预措施
Parathyroid Eye (PTeye)
For patients assigned to the study arm, the surgeon will use the PTeye as an intraoperative tool to identify if a suspect tissue is a parathyroid or not, during the parathyroid surgery.
干预措施: Parathyroid Eye (PTeye) (Device)
Usual Standard of Care
The surgeon will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations.
结局指标
主要结局
Median Number of Frozen Sections (or Parathyroid Aspirate) Sent for Analysis
时间窗: At the end of the parathyroidectomy, up to 5 hours
Median number of frozen sections (or aspirate) sent for analysis during the parathyroidectomy (PTx) procedure to confirm potential parathyroid tissue
次要结局
- Number of Participants With Persistent Hyperparathyroidism (Immediate)(5-14 days after PTx procedure)
- Number of Participants With Persistent Hyperparathyroidism or Hypercalcemia (Transient)(5-14 days after PTx procedure)
- Number of Participants Persistent Hyperparathyroidism or Hypercalcemia (Failed Parathyroidectomy)(Up to 6 months after PTx procedure)
- Number of Parathyroid Glands (PG) Identified(At the end of the parathyroidectomy, up to 5 hours)
- Median Number of Parathyroid Glands Identified With NIRAF (PTeye Group Only)(At the end of the parathyroidectomy, up to 5 hours)
- Median Number of Diseased Parathyroid Glands Identified Versus Preoperatively Localized Glands(At the end of the parathyroidectomy, up to 5 hours)
- Median Number of Intra-operative Parathyroid Hormone (PTH) Assays Sent(At the end of the parathyroidectomy, up to 5 hours)
- Median Duration Taken to Identify First Parathyroid Gland(During parathyroidectomy, up to 5 hours)
- Median Duration Taken to Identify Last Parathyroid Gland(At the end of the parathyroidectomy, up to 5 hours)
- Median Duration of Parathyroidectomy (PTx) Procedure(Up to 5 hours)
- Median Duration for Intraoperative Parathyroid Hormone (PTH) to Normalize(At the end of the parathyroidectomy, up to 5 hours)
- Median Number of Nights in the Hospital After Parathyroidectomy(0-72 hours after PTx procedure)
- Median Number of 'False Positive' Tissue Samples Excised by Surgeon(Up to 10 days after PTx procedure)
- Number of Participants With Reported Doctor Visits/Emergency Department Visits or Hospital Admissions(Up to 6 months after PTx procedure)
- Number of Participants Who Have Had Repeat Parathyroidectomy (PTx) Procedure(From 6 - 12 months after PTx procedure)