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Evaluation of Coblation Channeling in Treating Chronic Tonsillitis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01193790
First Posted: September 2, 2010
Last Update Posted: September 20, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hillel Yaffe Medical Center
  Purpose
The investigators wish to evaluate coblation channeling in the treatment of chronic tonsillitis.

Condition Intervention Phase
Tonsillitis Procedure: Coblation channeling Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • RF coblation may be promising in treating chronic tonsillitis. [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • RF coblation reduces tonsillar volume and pain in comparison to surgery; may be performed as an out-patient procedure. [ Time Frame: 2 years ]

Estimated Enrollment: 60
Study Start Date: January 2011
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

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Ages Eligible for Study:   14 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01193790


Locations
Israel
Hillel Yaffe MC, Recruiting
Hadera, Israel, 38100
Contact: Itzhak Braverman, MD    972-4-630-4549    braverman@hy.health.gov.il   
Principal Investigator: Itzhak Braverman, MD         
Sponsors and Collaborators
Hillel Yaffe Medical Center
  More Information

Responsible Party: I. Braverman, MD, Hillel Yaffe MC, Hadera, Israel
ClinicalTrials.gov Identifier: NCT01193790     History of Changes
Other Study ID Numbers: 43-2001
First Submitted: September 1, 2010
First Posted: September 2, 2010
Last Update Posted: September 20, 2010
Last Verified: September 2010

Keywords provided by Hillel Yaffe Medical Center:
chronic tonsillitis
radio-frequency coblation
radio-frequency coblation in chronic tonsillitis treatment

Additional relevant MeSH terms:
Tonsillitis
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases