A Prospective, Multi-center, Single Arm Study of BiZact™ on Children and Adolescents Undergoing Tonsillectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Number of Patients With Intra-operative Blood Loss
研究概览
简要总结
The purpose of this study is to assess safety and performance with the use of the BiZact™ device in tonsillectomy procedures in children and adolescents.
详细描述
A prospective, multi-center, single arm, study of BiZact™ on children and adolescents undergoing tonsillectomy.
Study Visits:
- Screening/Baseline
- Surgery, Day 0
- Post-Op Follow-up Day 1 - Day 7, Day 10, & Day 14 (Home assessments)
- Post-Op Follow-up Day 28 (Office Visit)
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
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adolescent subjects 2-12 years of age at the time of the procedure, inclusive
- •Scheduled to undergo tonsillectomy
- •The subject and subject's Legally Authorized Representative (LAR) is willing to participate and consents to participate, as documented by signed informed consent form and/ or assent form (as applicable)
排除标准
- •Subjects undergoing:
- •Tonsillectomy as a result of cancer
- •Unilateral tonsillectomy
- •Subjects with:
- •Known Bleeding disorders
- •History of peritonsillar abscess
- •Craniofacial disorders
- •Down's syndrome (Trisomy 21)
- •Cerebral palsy
- •Major heart disease (including but not limited to; right-sided heart failure, left-sided heart failure, congestive heart failure, coronary artery disease, arrhythmias, chronic heart failure, acute heart failure, etc.)
- •Current tobacco use
- •Subjects unable to comply with the required study follow-up visits
- •Female subjects pregnant at time of procedure
- •The subject has comorbidities which, in the opinion of the Investigator, will not be appropriate for the study or the subject has an estimated life expectancy of less than 6 months.
- •The subject is participating or has participated in any drug or device research study within 30 days of enrollment.
研究组 & 干预措施
A bipolar instrument for tonsillectomies
A bipolar electrosurgical device that employs Radio frequency (RF) energy and pressure to ligate vessels interposed between its jaws which can then be transected using the built in knife deployed by the device trigger.
干预措施: BiZact™: A bipolar instrument for tonsillectomies (Device)
结局指标
主要结局
Number of Patients With Intra-operative Blood Loss
时间窗: During procedure
The study will be considered a success if the mean intra-operative blood loss is less than the mean intra-operative blood loss associated with conventional tonsillectomy in a large meta-analysis
Intra-operative Blood Loss
时间窗: During procedure
The study will be considered a success if the mean intra-operative blood loss is less than the mean intra-operative blood loss associated with conventional tonsillectomy in a large meta-analysis
次要结局
- "Number of Cases/Participants With Analgesic Consumption(28 days post-operatively)
- Number of Cases/Participants Rated Under Different Categories Based on the Performance of the Investigational Device(During Procedure)
- Post-operative Pain(Day 3)
- Number of Cases With Ability to Achieve Hemostasis (Performance of the Investigational Device)(During Procedure)
- Post-operative Pain(Post-operative Day 4)
- Post-operative Pain(Post-operative Day 5)
- Post-operative Pain(Post-operative Day 6)
- Post-operative Pain(Post-operative Day 7)
- Post-operative Pain(Post-operative Day 10)
- Post-operative Pain(Post-operative Day 14)
- Post-operative Pain(Post-operative Day 28)
- Post-operative Pain(Day 1)
- Post-operative Pain(Day 2)