Evaluation of Coblation Channeling in Treating Chronic Tonsillitis - Full Text View

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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Tonsils and Adenoids

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]


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.

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.

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

Eligibility


Ages Eligible for Study:	14 Years to 70 Years (Child, Adult, Senior)
Genders Eligible for Study:	Both
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

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Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	September 1, 2010
Last Updated:	September 17, 2010
Health Authority:	Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on September 30, 2016