Evaluation of Coblation Channeling in Treating Chronic Tonsillitis

Phase 2

• Conditions: Tonsillitis
• Interventions: Procedure: Coblation channeling

• Registration Number: NCT01193790
• Lead Sponsor: Hillel Yaffe Medical Center

Brief Summary

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

Detailed Description

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.

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

Study Timeline

• Status Verified: 2010-09
• Study First Submitted: 2010-09-01
• Study First Submitted QC: 2010-09-01
• Study First Posted: 2010-09-02
• Last Update Submitted: 2010-09-17
• Last Update Posted: 2010-09-20
• Study Start: 2011-01
• Primary Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coblation	Coblation channeling	-

Primary Outcome Measures

Name	Time	Method
RF coblation may be promising in treating chronic tonsillitis.	2 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hillel Yaffe MC,; 🇮🇱 Hadera, Israel