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/NCT06011369</url>
    </required_header>
    <id_info>
      <org_study_id>IMIB-SPAFLUO</org_study_id>
      <nct_id>NCT06011369</nct_id>
    </id_info>
    <brief_title>Study of Usefulness of Fluorescence in Thiroid Surgery</brief_title>
    <acronym>ECA_SPAFLUO</acronym>
    <official_title>A Prospective , Controlled, Randomized Multi-center Study on the Usefulness of Fluorescence in Thyroid Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        In thyroid surgery, the identification and preservation of the parathyroid glands and their&#xD;
        vascularization is essential to avoid postoperative hypoparathyroidism. In this sense,&#xD;
        fluorescence technology with autofluorescence (AF) can help us avoid this post-surgical&#xD;
        complication. This study aims to determine the advantages offered by fluorescence in thyroid&#xD;
        surgery, taking into account various clinical variables.&#xD;
  &#xD;
        For this, a randomized study is proposed in patients undergoing thyroid surgery with and&#xD;
        without cervical fluorescence.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>PROSPECTIVE, CONTROLLED, RANDOMIZED</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Type of surgery performed</measure>
      <time_frame>Up to 12 months.</time_frame>
      <description>total thyroidectomy/hemithyroidectomy; lymphadenectomy</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of parathyroid glands identified before the use of AF (Autofluorescence)</measure>
      <time_frame>Up to 12 months.</time_frame>
      <description>Gland count</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number and location of parathyroid glands identified with the use of FA (Autofluorescence)</measure>
      <time_frame>Up to 12 months.</time_frame>
      <description>Gland count</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quantification of each parathyroid gland with AF(Autofluorescence)</measure>
      <time_frame>Up to 12 months.</time_frame>
      <description>(two determinations in the same parathyroid gland, in total, eight determinations of the parathyroid glands parathyroid, and three determinations in the thyroid gland, the last being in a nodule if it'd exist</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of glands accidentally removed.</measure>
      <time_frame>Up to 12 months.</time_frame>
      <description>Gland count</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of autotransplanted glands.</measure>
      <time_frame>Up to 12 months.</time_frame>
      <description>Gland count</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Surgical time.</measure>
      <time_frame>Up to 12 months.</time_frame>
      <description>Hours of surgery</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of previous thyroidectomies performed with FA (Autofluorescence)(learning curve)</measure>
      <time_frame>Up to 12 months.</time_frame>
      <description>Number of surgeries using autofluorescence</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Concentration of PTH and calcium corrected by albumin and/or ionic</measure>
      <time_frame>4, 24 Hours</time_frame>
      <description>Value in analytics</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Concentration of PTH and calcium corrected by albumin and/or ionic</measure>
      <time_frame>6,12 Months</time_frame>
      <description>Value in analytics</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">260</enrollment>
    <condition>Thyroid Surgery</condition>
    <arm_group>
      <arm_group_label>Fluorescence in thyroid surgery</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients undergoing thyroid surgery with cervical fluorescence.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>No Fluorescence in thyroid surgery</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>patients undergoing thyroid surgery without cervical fluorescence.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Fluorescence in thyroid surgery</intervention_name>
      <description>Fluorescence in thyroid surgery</description>
      <arm_group_label>Fluorescence in thyroid surgery</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Total thyroidectomy with/without lymph node dissection&#xD;
  &#xD;
            -  Signature of informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients under 18 years of age&#xD;
  &#xD;
            -  Hemithyroidectomy&#xD;
  &#xD;
            -  Reintervention of thyroid surgery&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Beatriz Febrero, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>HCUVA</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Beatriz Febrero, MD</last_name>
      <phone>968 36 95 00</phone>
      <email>beatriz.febrero@um.es</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hospital Clínico Universitario Virgen de la Arrixaca</name>
        <address>
          <city>Murcia</city>
          <zip>30120</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Beatriz Febrero, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 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>Thyroid Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06011369
  org study id: IMIB-SPAFLUO
  nct id: NCT06011369
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In thyroid surgery, the identification and preservation of the parathyroid glands and their
        vascularization is essential to avoid postoperative hypoparathyroidism. In this sense,
        fluorescence technology with autofluorescence (AF) can help us avoid this post-surgical
        complication. This study aims to determine the advantages offered by fluorescence in thyroid
        surgery, taking into account various clinical variables.
  
        For this, a randomized study is proposed in patients undergoing thyroid surgery with and
        without cervical fluorescence.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: PROSPECTIVE, CONTROLLED, RANDOMIZED
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Type of surgery performed
  time frame: Up to 12 months.
  description: total thyroidectomy/hemithyroidectomy; lymphadenectomy
  measure: Number of parathyroid glands identified before the use of AF (Autofluorescence)
  time frame: Up to 12 months.
  description: Gland count
  measure: Number and location of parathyroid glands identified with the use of FA (Autofluorescence)
  time frame: Up to 12 months.
  description: Gland count
  measure: Quantification of each parathyroid gland with AF(Autofluorescence)
  time frame: Up to 12 months.
  description: (two determinations in the same parathyroid gland, in total, eight determinations of the parathyroid glands parathyroid, and three determinations in the thyroid gland, the last being in a nodule if it'd exist
  measure: Number of glands accidentally removed.
  time frame: Up to 12 months.
  description: Gland count
  measure: Number of autotransplanted glands.
  time frame: Up to 12 months.
  description: Gland count
  measure: Surgical time.
  time frame: Up to 12 months.
  description: Hours of surgery
  measure: Number of previous thyroidectomies performed with FA (Autofluorescence)(learning curve)
  time frame: Up to 12 months.
  description: Number of surgeries using autofluorescence
  measure: Concentration of PTH and calcium corrected by albumin and/or ionic
  time frame: 4, 24 Hours
  description: Value in analytics
  measure: Concentration of PTH and calcium corrected by albumin and/or ionic
  time frame: 6,12 Months
  description: Value in analytics
  arm group label: Fluorescence in thyroid surgery
  arm group type: Experimental
  description: Patients undergoing thyroid surgery with cervical fluorescence.
  arm group label: No Fluorescence in thyroid surgery
  arm group type: No Intervention
  description: patients undergoing thyroid surgery without cervical fluorescence.
  intervention type: Procedure
  intervention name: Fluorescence in thyroid surgery
  description: Fluorescence in thyroid surgery
  arm group label: Fluorescence in thyroid surgery
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Beatriz Febrero, MD
  role: Principal Investigator
  affiliation: HCUVA
  last name: Beatriz Febrero, MD
  phone: 968 36 95 00
  email: beatriz.febrero@um.es
  facility: 
  status: Recruiting
  investigator: 
  country: Spain
  responsible party type: Sponsor
  mesh term: Thyroid Diseases
  sharing ipd: No