Evaluation of Coblation Channeling in Treating Chronic Tonsillitis

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

Study Overview

• Status: Unknown
• Conditions: Tonsillitis
• Intervention / Treatment: Procedure: Coblation channeling

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Hadera, Israel, 38100
    • Hillel Yaffe MC,
    • Contact: Itzhak Braverman, MD; Phone Number: 972-4-630-4549; Email: braverman@hy.health.gov.il
    • Principal Investigator: Itzhak Braverman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Coblation

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
RF coblation may be promising in treating chronic tonsillitis.	2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hillel Yaffe Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: September 1, 2010
• First Submitted That Met QC Criteria: September 1, 2010
• First Posted (Estimate): September 2, 2010

Study Record Updates

• Last Update Posted (Estimate): September 20, 2010
• Last Update Submitted That Met QC Criteria: September 17, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: chronic tonsillitis; radio-frequency coblation; radio-frequency coblation in chronic tonsillitis treatment
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pharyngitis; Tonsillitis
• Other Study ID Numbers: 43-2001