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
- 2
- 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
研究组 & 干预措施
A bipolar instrument for tonsillectomies
A bipolar electrosurgical device that employs 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: A bipolar instrument for tonsillectomies (Device)
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
Pain Assessment Using a Visual Analog Scale (VAS)
时间窗: Post-operative Day 1
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
Pain Assessment Using a Visual Analog Scale (VAS)
时间窗: Post-operative Day 2
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
Pain Assessment Using a Visual Analog Scale (VAS)
时间窗: Post-operative Day 3
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
Pain Assessment Using a Visual Analog Scale (VAS)
时间窗: Post-operative Day 4
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
Pain Assessment Using a Visual Analog Scale (VAS)
时间窗: Post-operative Day 5
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
Pain Assessment Using a Visual Analog Scale (VAS)
时间窗: Post-operative Day 6
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
Pain Assessment Using a Visual Analog Scale (VAS)
时间窗: Post-operative Day 7
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
Pain Assessment Using a Visual Analog Scale (VAS)
时间窗: Post-operative Day 10
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)