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临床试验/NCT01193790
NCT01193790Unknown2 期

Evaluation of Coblation Channeling in Treating Chronic Tonsillitis

Hillel Yaffe Medical Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年1月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
入组人数
60
试验地点
1
主要终点
RF coblation may be promising in treating chronic tonsillitis.

研究概览

简要总结

The investigators wish to evaluate coblation channeling in the treatment of chronic tonsillitis.

详细描述

The tonsillar crypts play an important role in chronic tonsillitis. They are covered by stratified epithelium and may be initiated via the epithelium to mount immune responses to various presenting antigens. Go M. et al, investigated the expression and function of tight junctions in the epithelium of human palatine tonsils from patients with tonsillar hypertrophy or recurrent tonsillitis. These studies suggested unique expression of tight junctions in human palatine tonsillar epithelium, and it was suggested that the crypt epithelium may possess an epithelial barrier different from that of the surface epithelium.

Bacteria within biofilms are resistant to host defenses and antibiotics. The presence of bacterial biofilms within the tissue and crypts of inflamed tonsils may explain the chronicity and recurrent characteristics of some forms of tonsillitis. There is strong anatomical evidence for the presence of bacterial biofilms in chronically diseased tonsils.

Our hypothesis was that treatment of the crypts and tonsillar tissue may decrease the possible antigen-immune system interaction and inflammation.

The combination of the radio frequency energy and the fluid creates a "plasma" field containing highly ionized particles. The ionized particles have sufficient energy to break organic molecular bonds that can remove tissue selectively without excessive heat production and damage the surrounding tissue. Employing this new technique, the investigators will try to eliminate the cause for chronic tonsillitis.

The combination of the radio frequency energy and the fluid creates a "plasma" field containing highly ionized particles. The ionized particles have sufficient energy to break organic molecular bonds that can remove tissue selectively without excessive heat production and damage the surrounding tissue. Employing this new technique, the investigators will try to eliminate the cause for chronic tonsillitis.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
14 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •suffering from at least 4 episodes of tonsillitis in past year.
  • •suffering from recurrent or chronic sore throat.
  • •suffering from irregular tonsils with crypts, slight redness or enlargement.

排除标准

  • •suffering from mouth ulcers or other oral מחלת ריריות
  • •allergic to the type of medication included in the study.
  • •suffering from gastrointestinal (GI) reflux or chronic הפרשה הוסטנזלית
  • •contraindication to medical or surgical treatment.
  • •suffering from peritonsillar abscess.

研究组 & 干预措施

Coblation

Experimental

干预措施: Coblation channeling (Procedure)

结局指标

主要结局

RF coblation may be promising in treating chronic tonsillitis.

时间窗: 2 years

次要结局

  • RF coblation reduces tonsillar volume and pain in comparison to surgery; may be performed as an out-patient procedure.(2 years)

研究者

申办方类型
Other Gov

研究点 (1)

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