Evaluation of Coblation Channeling in Treating Chronic Tonsillitis
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| ClinicalTrials.gov Identifier: NCT01193790 |
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Recruitment Status : Unknown
Verified September 2010 by Hillel Yaffe Medical Center.
Recruitment status was: Not yet recruiting
First Posted : September 2, 2010
Last Update Posted : September 20, 2010
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Tonsillitis | Procedure: Coblation channeling | Phase 2 |
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 (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Study Start Date : | January 2011 |
| Estimated Primary Completion Date : | December 2012 |
| 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. |
- RF coblation may be promising in treating chronic tonsillitis. [ Time Frame: 2 years ]
- RF coblation reduces tonsillar volume and pain in comparison to surgery; may be performed as an out-patient procedure. [ Time Frame: 2 years ]
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| Ages Eligible for Study: | 14 Years to 70 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts 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.
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
| 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 | |
| Responsible Party: | I. Braverman, MD, Hillel Yaffe MC, Hadera, Israel |
| ClinicalTrials.gov Identifier: | NCT01193790 History of Changes |
| Other Study ID Numbers: |
43-2001 |
| First Posted: | September 2, 2010 Key Record Dates |
| Last Update Posted: | September 20, 2010 |
| Last Verified: | September 2010 |
Keywords provided by Hillel Yaffe Medical Center:
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chronic tonsillitis radio-frequency coblation radio-frequency coblation in chronic tonsillitis treatment |
Additional relevant MeSH terms:
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Tonsillitis Pharyngitis Pharyngeal Diseases Stomatognathic Diseases |
Respiratory Tract Infections Respiratory Tract Diseases Otorhinolaryngologic Diseases |