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Evaluation of Coblation Channeling in Treating Chronic Tonsillitis

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01193790
Enrollment
60
Registered
2010-09-02
Start date
2011-01-31
Completion date
Unknown
Last updated
2010-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tonsillitis

Keywords

chronic tonsillitis, radio-frequency coblation, radio-frequency coblation in chronic tonsillitis treatment

Brief summary

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

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.

Interventions

PROCEDURECoblation 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.

Sponsors

Hillel Yaffe Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
RF coblation may be promising in treating chronic tonsillitis.2 years

Secondary

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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026