Evaluation of Coblation Channeling in Treating Chronic Tonsillitis

Tonsillitis Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01193790
• Other study ID #: 43-2001
• Status: Not yet recruiting
• Phase: Phase 2
• First received: September 1, 2010
• Last updated: September 17, 2010
• Start date: January 2011

Study information

• Verified date: September 2010
• Source: Hillel Yaffe Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 70 Years

Eligibility

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 ???? ??????

• allergic to the type of medication included in the study.

• suffering from gastrointestinal (GI) reflux or chronic ????? ?????????

• contraindication to medical or surgical treatment.

• suffering from peritonsillar abscess.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tonsillitis

Intervention

Procedure:
• Coblation channeling
The combination of the energy and the fluid creates a "plasma" field containing highly ionized particles (coblation). The ionized particles have sufficient energy to break organic molecular bonds that can remove tissue selectively without excessive heat production and subsequent damage to the surrounding tissue. Treatment of the tonsillar crypts and tissue by coblation may decrease antigen and immune system interaction and inflammation.

Locations

Country	Name	City	State
Israel	Hillel Yaffe MC,	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RF coblation may be promising in treating chronic tonsillitis.		2 years	No
Secondary	RF coblation reduces tonsillar volume and pain in comparison to surgery; may be performed as an out-patient procedure.		2 years	No