<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02981810</url>
  </required_header>
  <id_info>
    <org_study_id>0046-16-HYMC</org_study_id>
    <nct_id>NCT02981810</nct_id>
  </id_info>
  <brief_title>Evaluation of Coblation Channeling Treatment for Chronic Tonsillitis.</brief_title>
  <official_title>Evaluation of Coblation Channeling Treatment for Chronic Tonsillitis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hillel Yaffe Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hillel Yaffe Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate coblation channeling treatment for chronic tonsillitis. Does Tonsillar ablation&#xD;
      can create changing in the tonsillar medium for recurrent tonsillar infections and stop the&#xD;
      recurrent infections?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The palatine tonsil consists of an epithelial crypt (invaginated pocket) surrounded by dense&#xD;
      clusters of lymph nodules, each with a germinal center where lymphocytes proliferate. The&#xD;
      nodules are embedded in a mass of diffuse lymphoid tissue that consists of lymphocytes&#xD;
      migrating to and from the germinal centers.&#xD;
&#xD;
      Increasing the surface area of the crypts is one way to facilitate the contact of antigens&#xD;
      (bacteria) with the immune cells. The epithelium may specialize to form an openmeshwork of&#xD;
      cells which allows the infiltration of the epithelium by lymphocytes and macrophages.&#xD;
      Tonsillar lymphoid nodules consist mainly of B-lymphocytes. Other areas are occupied by&#xD;
      T-lymphocytes, activated B-lymphocytes and other cells of the immune system. Inside the&#xD;
      crypts, where cells of the immune system often invade the epithelium, it will be difficult to&#xD;
      find the specific boundary between epithelium and lymphoid tissue. The bacterial material and&#xD;
      biofilms1 sits in crypts and may start a new infection from time to time. The epithelium&#xD;
      lining the crypt corresponds with that on the adjacent surface - stratified squamous in the&#xD;
      tongue and palate or pseudo stratified columnar in the pharynx. In either case, the&#xD;
      epithelium may be heavily infiltrated with lymphocytes, and the crypt may be filled with&#xD;
      lymphocytes and other debris.&#xD;
&#xD;
      The tonsillar crypts have an important role in chronic tonsillitis. They are covered by&#xD;
      stratified epithelium and may be initiated via the epithelium to mount immune responses to&#xD;
      various presenting antigens. Go M. et al, investigated the expression and function of tight&#xD;
      junctions in the epithelium of human palatine tonsils from patients with tonsillar&#xD;
      hypertrophy or recurrent tonsillitis. These studies suggested unique expression of tight&#xD;
      junctions in human palatine tonsillar epithelium, and it was suggested that the crypt&#xD;
      epithelium may possess an epithelial barrier different from that of the surface epithelium2.&#xD;
&#xD;
      Bacteria within biofilms are resistant to host defenses and antibiotics. The presence of&#xD;
      bacterial biofilms within the tissue and crypts of inflamed tonsils may explain the chronic&#xD;
      and recurrent characteristics of some forms of tonsillitis. There is strong anatomical&#xD;
      evidence for the presence of bacterial biofilms in chronically diseased tonsils1. Using a&#xD;
      novel visualization approach in single sections of human mucosal tissue, the presence of&#xD;
      biofilms was demonstrated on tonsils in most (17/24 [70.8%]) patients with tonsillitis3.&#xD;
&#xD;
      One study investigated the difference in follicle size and numbers in tonsils for patients&#xD;
      with tonsillar hypertrophy and recurrent tonsillitis using an image analysis method. There&#xD;
      was no significant difference in the mean follicle numbers per counting field between&#xD;
      recurrent tonsillitis and tonsillar hypertrophy. However, they demonstrated that tonsillar&#xD;
      hypertrophy is characterized histologically by an enlargement of follicles compared with&#xD;
      recurrent tonsillitis, indicating a hyperplastic condition of lymphoid cells in the germinal&#xD;
      centers. It may also explain the difference in etiology and immune mechanism between&#xD;
      tonsillar hypertrophy and recurrent tonsillitis4.&#xD;
&#xD;
      Coblation is a non-heat driven process in which radiofrequency energy is applied to a&#xD;
      conductive medium (usually saline) causing a highly focused plasma field to form around the&#xD;
      electrodes. The plasma field is comprised of highly ionized particles. These ionized&#xD;
      particles have sufficient energy to break organic molecular bonds within tissue. Instead of&#xD;
      exploding tissue, coblation causes a low-temperature molecular disintegration, resulting in&#xD;
      minimal tissue damage to surrounding areas.&#xD;
&#xD;
      A novel treatment for chronic tonsillitis is now suggested by the inventors, this method&#xD;
      being based on treating the source of recurrent bacterial infections in the tonsillar tissue,&#xD;
      specifically the tonsillar crypts.&#xD;
&#xD;
      By treatment of the crypts and tonsillar tissue it may be possible to decrease the possible&#xD;
      antigen-immune system interaction and inflammation.&#xD;
&#xD;
      Without being bound to a specific theory, it is suggested that the combination of the radio&#xD;
      frequency energy and the fluid creates a &quot;plasma&quot; field containing highly ionized particles,&#xD;
      which have sufficient energy to break organic molecular bonds that can remove tissue&#xD;
      selectively without excessive heat production and damage the surrounding tissue.&#xD;
&#xD;
      Material and Methods&#xD;
&#xD;
      The study protocol was approved by the The Hillel Yaffe Medical Center's Ethics and Helsinki&#xD;
      Committee.&#xD;
&#xD;
      60 patients suffering from chronic tonsillitis will be treated by Coblation channeling to the&#xD;
      tonsils.&#xD;
&#xD;
      The treatment was conducted using an Arthrocare® Corporation (ArthroCare Corporation, 7500&#xD;
      Rialto Boulevard Austin, Texas 78735) COBLATION electrode ReFlex Ultra 55* for tonsillar&#xD;
      tissue ablation at low temperatures with only one treatment. All the patients underwent&#xD;
      tonsil channeling treatment with coblation, and 4-6 channels were done in each tonsil under&#xD;
      local anesthesia, in the operating room. The patients were observed overnight.&#xD;
&#xD;
      A control group included 60 patients with chronic tonsillitis with indication for&#xD;
      tonsillectomy will underwent tonsillectomy.&#xD;
&#xD;
      The patients selected are older than 18 years old, and were healthy, without any chronic&#xD;
      diseases other than chronic tonsillitis. Diagnosis of chronic tonsillitis was based on&#xD;
      history and medical examination. The criteria were: 1. At least 4 occasions of tonsillitis in&#xD;
      the last year that were treated (positive throat swab for Streptococci Group A will&#xD;
      contribute towards the diagnosis). 2. Recurrent or chronic throat pain. 3. Hypertrophic&#xD;
      tonsils of chronic tonsillitis. Patients that were not included: 1. Disease of the mouth or&#xD;
      pharyngeal mucosa-like ulcers. 2. Allergy to drugs. 3. Gastrointestinal reflux. 4. Any&#xD;
      contraindication for tonsillectomy. 5. Peritonsillar abscess in the past.&#xD;
&#xD;
      Final evaluations were by follow-up of the patients 1,2,4,6 and 12 months after the beginning&#xD;
      of treatment. At each visit, evaluation of the treatment was done by investigating the degree&#xD;
      of throat pain or tonsillitis after the treatment, number of tonsillitis per year,&#xD;
      examination of the tonsils, post treatment pain score by VISUAL-ANALOG-SCALE (VAS) SCORES.&#xD;
      The following parameters were recorded: the size of tonsils before and after treatment,&#xD;
      number of occurrences of tonsillitis after one year, and if there was any post-treatment&#xD;
      bleeding.&#xD;
&#xD;
      The results will be statistically evaluated .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the number of visits at the doctor due to throat pain- using a questionnaire</measure>
    <time_frame>12 months</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the number of antibiotic treatment was indicated after the procedure- using a questionnaire</measure>
    <time_frame>12 month</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>questionnaires to subjectively evaluate the change in patient's discomfort while swallowing</measure>
    <time_frame>12 month</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>visual documentation of the pharynx with video camera</measure>
    <time_frame>12 month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>post operative pain assessment via VAS (VISUAL ANALOG SCALE) scores</measure>
    <time_frame>up to 7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>location and amount of bleeding- post surgical documentation</measure>
    <time_frame>up to 7 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Chronic Tonsillitis</condition>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>tonsillectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>coblation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>coblation of the tonsills</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Arthrocare® Corporation (ArthroCare Corporation, 7500 Rialto Boulevard Austin, Texas 78735) COBLATION electrode ReFlex Ultra 55*</intervention_name>
    <description>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.</description>
    <arm_group_label>coblation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>tonsillectomy</intervention_name>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients without any chronic diseases other than chronic tonsillitis. Diagnosis of&#xD;
             chronic tonsillitis is based on history and medical examination. The criteria are: 1.&#xD;
             At least 3 occasions of tonsillitis in the last year that were treated (positive&#xD;
             throat swab for Streptococci Group A will contribute towards the diagnosis). 2.&#xD;
             Recurrent or chronic throat pain. 3. Hypertrophic tonsils of chronic tonsillitis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Disease of the mouth or pharyngeal mucosa-like ulcers.&#xD;
&#xD;
          -  Allergy to drugs.&#xD;
&#xD;
          -  Gastrointestinal reflux.&#xD;
&#xD;
          -  Peritonsillar abscess in the past.&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Oncologic patients&#xD;
&#xD;
          -  Hematologic disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>December 1, 2016</last_update_submitted>
  <last_update_submitted_qc>December 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hillel Yaffe Medical Center</investigator_affiliation>
    <investigator_full_name>Itzhak Braverman</investigator_full_name>
    <investigator_title>Assitant Proffessor</investigator_title>
  </responsible_party>
  <keyword>TONSILLAR COBLATION</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tonsillitis</mesh_term>
    <mesh_term>Chronic Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02981810
org study id: 0046-16-HYMC
nct id: NCT02981810
lead sponsor: 
has dmc: No
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?
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 .
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in the number of visits at the doctor due to throat pain- using a questionnaire
time frame: 12 months
description: 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
measure: Change in the number of antibiotic treatment was indicated after the procedure- using a questionnaire
time frame: 12 month
description: 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
measure: questionnaires to subjectively evaluate the change in patient's discomfort while swallowing
time frame: 12 month
description: 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
measure: visual documentation of the pharynx with video camera
time frame: 12 month
measure: post operative pain assessment via VAS (VISUAL ANALOG SCALE) scores
time frame: up to 7 days
measure: location and amount of bleeding- post surgical documentation
time frame: up to 7 days
arm group label: control
arm group type: Active Comparator
description: tonsillectomy
arm group label: coblation
arm group type: Experimental
description: coblation of the tonsills
intervention type: Device
intervention name: Arthrocare® Corporation (ArthroCare Corporation, 7500 Rialto Boulevard Austin, Texas 78735) COBLATION electrode ReFlex Ultra 55*
description: 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.
arm group label: coblation
intervention type: Procedure
intervention name: tonsillectomy
arm group label: control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Hillel Yaffe Medical Center
investigator full name: Itzhak Braverman
investigator title: Assitant Proffessor
mesh term: Tonsillitis
mesh term: Chronic Disease
sharing ipd: Undecided