Evaluation of Coblation Channeling in Treating Chronic Tonsillitis

Hillel Yaffe Medical Center

Status and phase: Unknown; Phase 2

Conditions: Tonsillitis

Treatments: Procedure: Coblation channeling

Study type: Interventional

Funder types: Other

Identifiers

NCT01193790

43-2001

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 14 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Coblation

Experimental group

Treatment:

Procedure: Coblation channeling