A Prospective, Randomized, Double-blinded, Controlled Study to Evaluate Use of the PEAK PlasmaBlade TnA in Subcapsular Tonsillectomy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 51
- 试验地点
- 4
- 主要终点
- Post-operative Pain
研究概览
简要总结
The objective of this clinical study is to evaluate the operative performance of the PEAK PlasmaBlade® TnA during subcapsular tonsillectomy; to monitor and record post-operative clinical outcome variables; and to compare these endpoints to the Standard of Care (SOC).
详细描述
Tonsillectomy is performed in response to cases of repeated occurrence of acute tonsillitis or adenoiditis, obstructive sleep apnea, nasal airway obstruction, snoring, or peritonsillar abscess.
The PEAK PlasmaBlade uses pulsed radiofrequency (RF) energy and a highly-insulated handpiece design to enable precision cutting and coagulation at the point of application. The PlasmaBlade has received FDA clearance for use in plastic, general, orthopedic, and ear, nose, and throat (ENT) surgery, and has demonstrated a significantly reduced thermal injury profile in incised tissue compared to traditional electrosurgical devices. It is hypothesized that this benefit may improve the post-operative outcome of patients undergoing tonsillectomy.
Two study sites were granted approval for this prospective randomized study. Potential subjects were screened against the inclusion and exclusion criteria of the study protocol and were required to provide informed consent for themselves (adults) or for their child prior to enrollment. Following enrollment, subjects were prospectively randomized to the SOC or PlasmaBlade (PB or PEAK) study groups and scheduled for tonsillectomy or tonsillectomy and adenoidectomy (TnA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children & adolescents: Age 3-17; Adults: 18 and older
- •Physically healthy, stable weight
- •Requiring tonsillectomy and adenoidectomy per widely accepted indications
- •For adults, subject must understand the nature of the procedure and provide written informed consent.
- •For children and adolescents age 7 to 17, subject must understand the nature of the procedure and be able to give verbal assent prior to the procedure. In addition, parent or guardian must provide written informed consent.
- •For children under 7 years old, parent or guardian must understand the nature of the procedure and provide written informed consent.
- •Subject (or responsible parent or guardian) must be willing and able to comply with all follow-up evaluations, including completion of study data sheets.
排除标准
- •Children: Age 2 and under
- •Bleeding disorder
- •Peritonsillar abscess
- •Requiring concomitant uvulopalatopharyngoplasty (UPPP)
- •Anticoagulation therapy which cannot be discontinued
- •Unable to follow instructions or complete follow-up
- •Currently taking any medication known to affect healing
- •Currently enrolled in another investigational device or drug trial
结局指标
主要结局
Post-operative Pain
时间窗: 10 days immediately following surgery
The primary outcome measure will be pain in each treatment group, as measured by visual analog scale twice daily in the 10 day period directly following surgery.
次要结局
- Operative Time, Estimated Blood Loss (EBL), Diet Volume and Activity Level(1-2 weeks post-operatively)