A Prospective, Multi-center, Single Arm Non-comparative Pilot Study of BiZact™ on Adults Undergoing Tonsillectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 3
- 主要终点
- Pain Assessment Using a Visual Analog Scale (VAS)
研究概览
简要总结
The purpose of this study is to assess the severity of post-operative pain following the use of the BiZact™ device in adult (≥22 years of age in United States and ≥18 years of age in Europe) tonsillectomy procedures.
详细描述
Study Design: Prospective, multi-center, single-arm non-comparative pilot study to assess the severity of post-operative pain with the use of BiZact™ for tonsillectomy.
Study Visits:
- Screening
- Surgery, Day 0
- Post-Op Follow-up Day 1 - Day 7 & Day 10 (Home assessments)
- Post-Op Follow-up Day 14 (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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (male or female) ≥22 in United States and ≥18 years of age in Europe years of age
- •Scheduled to undergo tonsillectomy
- •Signed informed consent by subject
排除标准
- •Subjects undergoing:
- •Simultaneous adenoidectomy
- •Tonsillectomy as a result of cancer
- •Unilateral tonsillectomy
- •Current participation in other clinical trials
- •Subjects with:
- •Current tobacco use
- •Known bleeding disorders
- •History of peritonsillar abscess
- •Craniofacial disorders
- •Down 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.)
- •Subjects unable to comply with the required study follow-up visits
- •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
- •Any subject who is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity)
- •The subject has participated in any drug or device research study within 30 days of enrollment
结局指标
主要结局
Pain Assessment Using a Visual Analog Scale (VAS)
时间窗: Post-operative Day 14
The severity of post-operative pain following the use of the BiZact™ device in adult (≥22 years of age in United States and ≥18 years of age in Europe) tonsillectomy procedures will be analyzed at each post-operative assessment: at days 1 through 7, 10 and 14. This pain score will be assessed quantitatively using the VAS scale and qualitatively using the below subgroups: * No Pain: VAS= 0 * Mild Pain: VAS \> 0 and \< 4 * Moderate: VAS ≥ 4 and \< 7 * Severe: VAS ≥ 7
次要结局
- Time to Normal Diet Following the Use of the BiZact™ Device in Adult (≥22 Years of Age in United States and ≥18 Years of Age in Europe) Tonsillectomy Procedures(Post-operative Day 28)
- Time to Normal Activity Following the Use of the BiZact™ Device in Adult (≥22 Years of Age in United States and ≥18 Years of Age in Europe) Tonsillectomy Procedures(Post-operative Day 28)