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Evaluation of Coblation Channeling in Treating Chronic Tonsillitis

Primary Purpose

Tonsillitis

Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Coblation channeling
Sponsored by
Hillel Yaffe Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tonsillitis focused on measuring chronic tonsillitis, radio-frequency coblation, radio-frequency coblation in chronic tonsillitis treatment

Eligibility Criteria

14 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hillel Yaffe MC,

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Coblation

Arm Description

Outcomes

Primary Outcome Measures

RF coblation may be promising in treating chronic tonsillitis.

Secondary Outcome Measures

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

Full Information

First Posted
September 1, 2010
Last Updated
September 17, 2010
Sponsor
Hillel Yaffe Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01193790
Brief Title
Evaluation of Coblation Channeling in Treating Chronic Tonsillitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hillel Yaffe Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tonsillitis
Keywords
chronic tonsillitis, radio-frequency coblation, radio-frequency coblation in chronic tonsillitis treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Coblation
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Coblation channeling
Intervention Description
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.
Primary Outcome Measure Information:
Title
RF coblation may be promising in treating chronic tonsillitis.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
RF coblation reduces tonsillar volume and pain in comparison to surgery; may be performed as an out-patient procedure.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Hillel Yaffe MC,
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Itzhak Braverman, MD
Phone
972-4-630-4549
Email
braverman@hy.health.gov.il
First Name & Middle Initial & Last Name & Degree
Itzhak Braverman, MD

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Coblation Channeling in Treating Chronic Tonsillitis

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