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Chronic TonsillitisNCT02981810

Evaluation of Coblation Channeling Treatment for Chronic Tonsillitis.

A study testing Arthrocare® Corporation (ArthroCare Corporation, 7500 Rialto Boulevard Austin, Texas 78735) COBLATION electrode ReFlex Ultra 55* and tonsillectomy in people with Chronic Tonsillitis, run by Hillel Yaffe Medical Center.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To evaluate coblation channeling treatment for chronic tonsillitis. Does Tonsillar ablation can create changing in the tonsillar medium for recurrent tonsillar infections and stop the recurrent infections? Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Chronic Tonsillitis
What is being tested?
Arthrocare® Corporation (ArthroCare Corporation, 7500 Rialto Boulevard Austin, Texas 78735) COBLATION electrode ReFlex Ultra 55* and tonsillectomy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
No sites listed yet
Study dates
Dec 2016to Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients without any chronic diseases other than chronic tonsillitis. Diagnosis of chronic tonsillitis is based on history and medical examination. The criteria are: 1. At least 3 occasions of tonsillitis in the last year that were treated (positive throat swab for Streptococci Group A will contribute towards the diagnosis). 2. Recurrent or chronic throat pain. 3. Hypertrophic tonsils of chronic tonsillitis.

Who cannot join

  • Disease of the mouth or pharyngeal mucosa-like ulcers.
  • Allergy to drugs.
  • Gastrointestinal reflux.
  • Peritonsillar abscess in the past.
  • Pregnant women
  • Oncologic patients
  • Hematologic disease

About this study

To evaluate coblation channeling treatment for chronic tonsillitis. Does Tonsillar ablation can create changing in the tonsillar medium for recurrent tonsillar infections and stop the recurrent infections?

Read the detailed description

The palatine tonsil consists of an epithelial crypt (invaginated pocket) surrounded by dense clusters of lymph nodules, each with a germinal center where lymphocytes proliferate. The nodules are embedded in a mass of diffuse lymphoid tissue that consists of lymphocytes migrating to and from the germinal centers.

Increasing the surface area of the crypts is one way to facilitate the contact of antigens (bacteria) with the immune cells. The epithelium may specialize to form an openmeshwork of cells which allows the infiltration of the epithelium by lymphocytes and macrophages. Tonsillar lymphoid nodules consist mainly of B-lymphocytes. Other areas are occupied by T-lymphocytes, activated B-lymphocytes and other cells of the immune system. Inside the crypts, where cells of the immune system often invade the epithelium, it will be difficult to find the specific boundary between epithelium and lymphoid tissue. The bacterial material and biofilms1 sits in crypts and may start a new infection from time to time. The epithelium lining the crypt corresponds with that on the adjacent surface - stratified squamous in the tongue and palate or pseudo stratified columnar in the pharynx. In either case, the epithelium may be heavily infiltrated with lymphocytes, and the crypt may be filled with lymphocytes and other debris.

The tonsillar crypts have 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 epithelium2.

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 chronic and recurrent characteristics of some forms of tonsillitis. There is strong anatomical evidence for the presence of bacterial biofilms in chronically diseased tonsils1. Using a novel visualization approach in single sections of human mucosal tissue, the presence of biofilms was demonstrated on tonsils in most (17/24 [70.8%]) patients with tonsillitis3.

One study investigated the difference in follicle size and numbers in tonsils for patients with tonsillar hypertrophy and recurrent tonsillitis using an image analysis method. There was no significant difference in the mean follicle numbers per counting field between recurrent tonsillitis and tonsillar hypertrophy. However, they demonstrated that tonsillar hypertrophy is characterized histologically by an enlargement of follicles compared with recurrent tonsillitis, indicating a hyperplastic condition of lymphoid cells in the germinal centers. It may also explain the difference in etiology and immune mechanism between tonsillar hypertrophy and recurrent tonsillitis4.

Coblation is a non-heat driven process in which radiofrequency energy is applied to a conductive medium (usually saline) causing a highly focused plasma field to form around the electrodes. The plasma field is comprised of highly ionized particles. These ionized particles have sufficient energy to break organic molecular bonds within tissue. Instead of exploding tissue, coblation causes a low-temperature molecular disintegration, resulting in minimal tissue damage to surrounding areas.

A novel treatment for chronic tonsillitis is now suggested by the inventors, this method being based on treating the source of recurrent bacterial infections in the tonsillar tissue, specifically the tonsillar crypts.

By treatment of the crypts and tonsillar tissue it may be possible to decrease the possible antigen-immune system interaction and inflammation.

Without being bound to a specific theory, it is suggested that the combination of the radio frequency energy and the fluid creates a "plasma" field containing highly ionized particles, which have sufficient energy to break organic molecular bonds that can remove tissue selectively without excessive heat production and damage the surrounding tissue.

Material and Methods

The study protocol was approved by the The Hillel Yaffe Medical Center's Ethics and Helsinki Committee.

60 patients suffering from chronic tonsillitis will be treated by Coblation channeling to the tonsils.

The treatment was conducted using an Arthrocare® Corporation (ArthroCare Corporation, 7500 Rialto Boulevard Austin, Texas 78735) COBLATION electrode ReFlex Ultra 55* for tonsillar tissue ablation at low temperatures with only one treatment. All the patients underwent tonsil channeling treatment with coblation, and 4-6 channels were done in each tonsil under local anesthesia, in the operating room. The patients were observed overnight.

A control group included 60 patients with chronic tonsillitis with indication for tonsillectomy will underwent tonsillectomy.

The patients selected are older than 18 years old, and were healthy, without any chronic diseases other than chronic tonsillitis. Diagnosis of chronic tonsillitis was based on history and medical examination. The criteria were: 1. At least 4 occasions of tonsillitis in the last year that were treated (positive throat swab for Streptococci Group A will contribute towards the diagnosis). 2. Recurrent or chronic throat pain. 3. Hypertrophic tonsils of chronic tonsillitis. Patients that were not included: 1. Disease of the mouth or pharyngeal mucosa-like ulcers. 2. Allergy to drugs. 3. Gastrointestinal reflux. 4. Any contraindication for tonsillectomy. 5. Peritonsillar abscess in the past.

Final evaluations were by follow-up of the patients 1,2,4,6 and 12 months after the beginning of treatment. At each visit, evaluation of the treatment was done by investigating the degree of throat pain or tonsillitis after the treatment, number of tonsillitis per year, examination of the tonsils, post treatment pain score by VISUAL-ANALOG-SCALE (VAS) SCORES. The following parameters were recorded: the size of tonsils before and after treatment, number of occurrences of tonsillitis after one year, and if there was any post-treatment bleeding.

The results will be statistically evaluated .

Being tested
Arthrocare® Corporation (ArthroCare Corporation, 7500 Rialto Boulevard Austin, Texas 78735) COBLATION electrode ReFlex Ultra 55*, tonsillectomy
Keywords
TONSILLAR COBLATION

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Arthrocare® Corporation (ArthroCare Corporation, 7500 Rialto Boulevard Austin, Texas 78735) COBLATION electrode ReFlex Ultra 55*Device

    The treatment was conducted using an Arthrocare® Corporation (ArthroCare Corporation, 7500 Rialto Boulevard Austin, Texas 78735) COBLATION electrode ReFlex Ultra 55* for tonsillar tissue ablation at low temperatures with only one treatment. All the patients underwent tonsil channeling treatment with coblation, and 4-6 channels were done in each tonsil under local anesthesia, in the operating room. The patients were observed overnight.

  • tonsillectomyProcedure or surgery

Study groups in NCT02981810
Study groupRoleWhat they receive
controlActive comparatortonsillectomy
Receives: Procedure: tonsillectomy
coblationExperimentalcoblation of the tonsills
Receives: Device: Arthrocare® Corporation (ArthroCare Corporation, 7500 Rialto Boulevard Austin, Texas 78735) COBLATION electrode ReFlex Ultra 55*

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the number of visits at the doctor due to throat pain- using a questionnaire

    the patient will be asked to report in specific time points in his/hers follow up: after 1 month, 2months, 4 months, 6 months and 12 months

    Measured: 12 months

  2. Change in the number of antibiotic treatment was indicated after the procedure- using a questionnaire

    the patient will be asked to report in specific time points in his/hers follow up: after 1 month, 2months, 4 months, 6 months and 12 months

    Measured: 12 month

  3. questionnaires to subjectively evaluate the change in patient's discomfort while swallowing

    the patient will be asked to report in specific time points in his/hers follow up: after 1 month, 2months, 4 months, 6 months and 12 months

    Measured: 12 month

  4. visual documentation of the pharynx with video camera

    Measured: 12 month

Secondary outcomes (2)
  1. post operative pain assessment via VAS (VISUAL ANALOG SCALE) scores

    Measured: up to 7 days

  2. location and amount of bleeding- post surgical documentation

    Measured: up to 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2016 (estimated)
  2. Study startDec 2016
  3. Primary completionDec 2018 (estimated)
  4. Study completionDec 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02981810
Sponsor's protocol ID
0046-16-HYMC
Status last verified
Dec 2016
First submitted
13 Nov 2016
Last updated
5 Dec 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Arthrocare® Corporation (ArthroCare Corporation, 7500 Rialto Boulevard Austin, Texas 78735) COBLATION electrode ReFlex Ultra 55* and tonsillectomy in people with Chronic Tonsillitis, run by Hillel Yaffe Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the number of visits at the doctor due to throat pain- using a questionnaire (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2016.

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