xml: <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/NCT05985837</url>
    </required_header>
    <id_info>
      <org_study_id>KG-01-2023</org_study_id>
      <nct_id>NCT05985837</nct_id>
    </id_info>
    <brief_title>Post Market Clinical Follow-Up Study - Medical Device KalobaGOLA ( PMCF )</brief_title>
    <acronym>PMCF</acronym>
    <official_title>Post Market Clinical Follow-Up Study on Medical Devices KalobaGola Useful for Sore Throat and/or Pharyngitis in Adults and Children</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Schwabe Pharma Italia</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Schwabe Pharma Italia</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this observational PMCF study is to confirm the efficacy and safety of the&#xD;
        medical device KalobaGola (oral spray and tablets) in children, adolescents and adults with&#xD;
        sore throat and /or pharyngitis. The main questions it aims to answer are:&#xD;
  &#xD;
          -  Is the product effective in the treatment of sore throat / pharyingits?&#xD;
  &#xD;
          -  Is the product safe?&#xD;
  &#xD;
        After buying the product, participants will be asked to fill in a questionnaire, in order to:&#xD;
  &#xD;
          1. Assess the sore throat symptoms before the use of the spray or tablets.&#xD;
  &#xD;
          2. Assess the resolution of sore throat / pharyngitis symptoms after the use of the spray&#xD;
             or tablets.&#xD;
  &#xD;
          3. Describe the adverse effect(s)/problem(s) observed while using the product (if any).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The Medical Device Regulation (EU) 2017/745 (MDR) considers post-market clinical follow-up&#xD;
        (PMCF) as a continuous process that aims to update the clinical evaluation and validate or&#xD;
        reassess the benefit-risk balance of the medical device. The PMCF is an integral part of the&#xD;
        manufacturer's post-market surveillance plan (PMS).&#xD;
  &#xD;
        The medical devices in question are both CE marked since 2020, with no substantial&#xD;
        modification.&#xD;
  &#xD;
        The objectives of this Post Market Clinical Follow Up (PMCF) study are: verify the use of&#xD;
        these devices in a real situation, verify if their efficacy and safety of use are aligned&#xD;
        with the provisions of the clinical evaluation; confirm or reassess the benefit/risk balance;&#xD;
        update the risk analysis; identify any need for CAPA.&#xD;
  &#xD;
        Specific product questionnaires have been developed based on the validated STAT-10&#xD;
        questionnaire, which aim to investigate aspects of Real-World Evidence on efficacy, safety,&#xD;
        even in specific categories or situations, known and unknown adverse events, difficulties in&#xD;
        use or completeness and clarity of IFUs.&#xD;
  &#xD;
        Given the low-risk class of the devices (class IIa - Dir. 93/42/EEC), which are intended for&#xD;
        use by lay people and normally sold in pharmacies / parapharmacies, the sponsor planned to&#xD;
        distribute the questionnaires to users that have purchased the product through health&#xD;
        professionals (pharmacists), who are normally in charge of the distribution of the products.&#xD;
  &#xD;
        The questionnaire was prepared in simple and easily understandable language for lay people.&#xD;
  &#xD;
        The data requested during the filling of the questionnaire does not provide for the&#xD;
        collection of information that allows the sponsor an identification of the participant.&#xD;
  &#xD;
        Data will be collected and processed in a totally anonymous form.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">August 2, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Resolution of the symptoms of sore throat / pharyngitis</measure>
      <time_frame>Before use and at the resolution (after maximum 7 days)</time_frame>
      <description>A 7-items close question questionnaire developed based on STAT-10 (Sore Throat Assessment Tool-10), a validated and published questionnaire. It is a five-points scale with values from 1 to 5 (1= not at all; 5 = very high degree).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Rate of known and unknown side-effects and / or other risks associated to the use of medical devices</measure>
      <time_frame>During and after use (from the first application to after maximum 7 days)</time_frame>
      <description>Safety of the devices during and after use</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Sore-throat</condition>
    <condition>Pharyngitis</condition>
    <arm_group>
      <arm_group_label>Adolescents and adults</arm_group_label>
      <description>Adolescents from 12 years old and adults with sore throat and/or pharyngitis, who have bought the product.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Children 1-6 years</arm_group_label>
      <description>Children from 1 to 6 years old with sore throat and/or pharyngitis, whose parents/caregivers have bought the product.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Children 6-12 years</arm_group_label>
      <description>Children from 6 to 12 years old with sore throat and/or pharyngitis, whose parents/caregivers have bought the product.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>KalobaGOLA spray (1)</intervention_name>
      <description>Oral spray, 2-4 spray, till 8 times per day</description>
      <arm_group_label>Adolescents and adults</arm_group_label>
      <arm_group_label>Children 6-12 years</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>KalobaGOLA spray (2)</intervention_name>
      <description>Oral spray, 2-4 spray, till 4 times per day</description>
      <arm_group_label>Children 1-6 years</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>KalobaGOLA tablets</intervention_name>
      <description>1 tablets, 6 times per day</description>
      <arm_group_label>Adolescents and adults</arm_group_label>
      <arm_group_label>Children 6-12 years</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Customers of the pharmacies/parapharmacies involved&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  KalobaGOLA spray: children from 1 year, adolescents and adults, both sexes, with&#xD;
               symptoms of sore throat (burning sensation, pharyngitis, pain on swallowing), who /&#xD;
               whose parents or caregivers bought the product by the pharmacy/parapharmacy involved.&#xD;
  &#xD;
            -  KalobaGOLA tablets: children from 6 years, adolescents and adults, both sexes, with&#xD;
               symptoms of sore throat (burning sensation, pharyngitis, pain on swallowing), who /&#xD;
               whose parents or caregivers bought the product by the pharmacy/parapharmacy involved.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  KalobaGOLA spray: children aged &lt; 1 year, people without sore throat symptoms&#xD;
  &#xD;
            -  KalobaGOLA tablets: children aged &lt; 6 years, people without sore throat symptoms&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Year</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Schwabe Pharma Italia</name>
        <address>
          <city>Egna</city>
          <state>Bolzano</state>
          <zip>39044</zip>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pharyngitis</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05985837
  org study id: KG-01-2023
  nct id: NCT05985837
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational PMCF study is to confirm the efficacy and safety of the
        medical device KalobaGola (oral spray and tablets) in children, adolescents and adults with
        sore throat and /or pharyngitis. The main questions it aims to answer are:
  
          -  Is the product effective in the treatment of sore throat / pharyingits?
  
          -  Is the product safe?
  
        After buying the product, participants will be asked to fill in a questionnaire, in order to:
  
          1. Assess the sore throat symptoms before the use of the spray or tablets.
  
          2. Assess the resolution of sore throat / pharyngitis symptoms after the use of the spray
             or tablets.
  
          3. Describe the adverse effect(s)/problem(s) observed while using the product (if any).
  The Medical Device Regulation (EU) 2017/745 (MDR) considers post-market clinical follow-up
        (PMCF) as a continuous process that aims to update the clinical evaluation and validate or
        reassess the benefit-risk balance of the medical device. The PMCF is an integral part of the
        manufacturer's post-market surveillance plan (PMS).
  
        The medical devices in question are both CE marked since 2020, with no substantial
        modification.
  
        The objectives of this Post Market Clinical Follow Up (PMCF) study are: verify the use of
        these devices in a real situation, verify if their efficacy and safety of use are aligned
        with the provisions of the clinical evaluation; confirm or reassess the benefit/risk balance;
        update the risk analysis; identify any need for CAPA.
  
        Specific product questionnaires have been developed based on the validated STAT-10
        questionnaire, which aim to investigate aspects of Real-World Evidence on efficacy, safety,
        even in specific categories or situations, known and unknown adverse events, difficulties in
        use or completeness and clarity of IFUs.
  
        Given the low-risk class of the devices (class IIa - Dir. 93/42/EEC), which are intended for
        use by lay people and normally sold in pharmacies / parapharmacies, the sponsor planned to
        distribute the questionnaires to users that have purchased the product through health
        professionals (pharmacists), who are normally in charge of the distribution of the products.
  
        The questionnaire was prepared in simple and easily understandable language for lay people.
  
        The data requested during the filling of the questionnaire does not provide for the
        collection of information that allows the sponsor an identification of the participant.
  
        Data will be collected and processed in a totally anonymous form.
  observational model: Case-Only
  time perspective: Prospective
  measure: Resolution of the symptoms of sore throat / pharyngitis
  time frame: Before use and at the resolution (after maximum 7 days)
  description: A 7-items close question questionnaire developed based on STAT-10 (Sore Throat Assessment Tool-10), a validated and published questionnaire. It is a five-points scale with values from 1 to 5 (1= not at all; 5 = very high degree).
  measure: Rate of known and unknown side-effects and / or other risks associated to the use of medical devices
  time frame: During and after use (from the first application to after maximum 7 days)
  description: Safety of the devices during and after use
  arm group label: Adolescents and adults
  description: Adolescents from 12 years old and adults with sore throat and/or pharyngitis, who have bought the product.
  arm group label: Children 1-6 years
  description: Children from 1 to 6 years old with sore throat and/or pharyngitis, whose parents/caregivers have bought the product.
  arm group label: Children 6-12 years
  description: Children from 6 to 12 years old with sore throat and/or pharyngitis, whose parents/caregivers have bought the product.
  intervention type: Device
  intervention name: KalobaGOLA spray (1)
  description: Oral spray, 2-4 spray, till 8 times per day
  arm group label: Adolescents and adults
  arm group label: Children 6-12 years
  intervention type: Device
  intervention name: KalobaGOLA spray (2)
  description: Oral spray, 2-4 spray, till 4 times per day
  arm group label: Children 1-6 years
  intervention type: Device
  intervention name: KalobaGOLA tablets
  description: 1 tablets, 6 times per day
  arm group label: Adolescents and adults
  arm group label: Children 6-12 years
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 1 Year
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Italy
  responsible party type: Sponsor
  mesh term: Pharyngitis