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/NCT06027710</url>
    </required_header>
    <id_info>
      <org_study_id>USC 68/2022</org_study_id>
      <nct_id>NCT06027710</nct_id>
    </id_info>
    <brief_title>Allograft Ridge Augmentation: 3D Analysis of CAD/CAM Custom Milled and Prefabricated Conventional Allogeneic Bone Blocks and Dental Implant Follow-up</brief_title>
    <official_title>Remodeling of Prefabricated Conventional and CAD/CAM Custom Fabricated Allograft Blocks for Bone Augmentation - Volumetric Analysis and Dental Implant Follow-up</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Santiago de Compostela</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Friedrich-Alexander-Universität Erlangen-Nürnberg</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Santiago de Compostela</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>
        To rehabilitate patients after the loss of their own teeth, dental implants are nowadays the&#xD;
        therapy of choice if the indication is suitable. In order to successfully place implants in&#xD;
        the patient's jaw, a sufficient supply of bone in vertical and horizontal dimensions is&#xD;
        necessary. Human bone is generally always in the process of reconstruction and changes over&#xD;
        time. If there is not enough substance left for rehabilitation with implants due to previous&#xD;
        degradation of the alveolar bone, bone augmentation can be performed. For this purpose,&#xD;
        mainly autogenous, xenogenic or allogenic bone material is used.&#xD;
  &#xD;
        Bone augmentation using allografts shows satisfactory results in clinical use and has&#xD;
        advantages such as elimination of morbidity associated with autogenous bone graft harvesting.&#xD;
        In addition to the use of conventional and prefabricated graft blocks, it is now possible to&#xD;
        produce individual allogeneic bone blocks using computer-aided design based on the patient's&#xD;
        radiological data. After this bone has been placed in the patient, it can be restored with&#xD;
        implants after a healing phase of about 6 months.&#xD;
  &#xD;
        In order to make the treatment as predictable as possible, it is crucial to know how a bone&#xD;
        augmentation changes over time and whether bone remodelling or resorption occurs. How&#xD;
        allogeneic bone blocks behave with regard to their stability and treatment success has&#xD;
        already been investigated in some studies, but to date there is no study that deals with the&#xD;
        difference between prefabricated, conventional and individually manufactured CAD/CAM&#xD;
        allogeneic bone blocks.&#xD;
  &#xD;
        By retrospectively analysing existing clinical data, the aim is to compare how the two&#xD;
        methods, prefabricated bone blocks and CAD/CAM-fabricated bone blocks, perform during the&#xD;
        healing phase.&#xD;
  &#xD;
        A virtual volume analysis method of 3D digital imaging data (cone beam computed tomography&#xD;
        scans) will be performed, which allows not only linear punctual evaluation but also area and&#xD;
        volumetric analysis. Furthermore, the in the grafts inserted dental implants will be examined&#xD;
        in terms of survival rate, complication rate and marginal bone loss by evaluation of the&#xD;
        available follow-up records of up to 12 years.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A clinical retrospective cohort study is planned in a non-invasive, observational study&#xD;
        design.&#xD;
  &#xD;
        The study will be conducted at a single university centre: the Department of Department of&#xD;
        Stomatology (Periodontology), Faculty of Dentistry, University of Santiago de Compostela,&#xD;
        Spain.&#xD;
  &#xD;
        The study will be conducted in the following steps:&#xD;
  &#xD;
          1. Identification of the patient population:&#xD;
  &#xD;
             The cohort for the retrospective study will be filtered from the patient data of the&#xD;
             Department of Stomatology (Periodontology) of the University of Santiago de Compostela.&#xD;
             Data from all patients who have received one of the following two treatments in the last&#xD;
             12 years will be selected and examined:&#xD;
  &#xD;
               -  Group A: horizontal and/or vertical augmentation of Puros® allogeneic bone graft&#xD;
                  material (Zimmer Biomet, Winterthur, Switzerland) in the upper and/or lower jaw;&#xD;
                  type: conventional prefabricated bone blocks.&#xD;
  &#xD;
               -  Group B: horizontal and/or vertical augmentation of allogeneic bone graft material&#xD;
                  Puros® (Zimmer Biomet, Winterthur, Switzerland) in the upper and/or lower jaw;&#xD;
                  Type: individually planned, CAD/CAM-produced bone blocks&#xD;
  &#xD;
          2. Data extraction:&#xD;
  &#xD;
             The following clinical data of the patients are collected for retrospective analysis:&#xD;
  &#xD;
               -  The patients anamnesis with age at the time of surgery, gender, smoking habits at&#xD;
                  the time of surgery and during the period of follow-up examinations up to 12 years&#xD;
                  after surgery&#xD;
  &#xD;
               -  The patients treatment history: Statements about the treatment and follow-up&#xD;
                  examinations during the period up to 12 years after the intervention, statements&#xD;
                  about adverse events and complications during the intervention or in the period of&#xD;
                  follow-up examinations up to 12 years after surgery, intraoral clinical photographs&#xD;
  &#xD;
             The following radiological data of patients from both groups are used for evaluation:&#xD;
             cone beam computed tomography data sets for volumetric evaluation and conventional&#xD;
             x-rays for implant follow-up investigation. In detail the last CBCT scan before surgery&#xD;
             (preoperative, t=0); the first CBCT scan directly after surgery (postoperative, t=1);&#xD;
             the CBCT scan at 6 months after surgery (control, t=2); all periapical X-rays in the&#xD;
             follow-up period of maximum 12 years after the surgery (Follow-up 1, Follow-up 2,&#xD;
             Follow-up 3...) of the bone blocks and the therein inserted implants.&#xD;
  &#xD;
             To ensure that no conclusion be drawn about the identity of the patient, the data are&#xD;
             pseudonymised by the investigating clinicians. The following type of pseudonymisation of&#xD;
             the data takes place: the evaluation of the data is pseudonymised, i.e. the patient's&#xD;
             name is replaced by another characteristic (number and letter, e.g. patient 1a, patient&#xD;
             2a, etc.). In this way, cases can be distinguished from patients and no conclusions can&#xD;
             be drawn about patients.&#xD;
  &#xD;
          3. Digital data analysis:&#xD;
  &#xD;
             Standard tesselation langugage (STL) data are evaluated linearly and also&#xD;
             volumetrically. First, STL models are created from the patients' DICOM data. The&#xD;
             pre-operative model serves as the baseline model for each patient. This data is imported&#xD;
             into CAD analysis software (GOM Inspect, GOM GmbH, Braunschweig, Germany). A region of&#xD;
             interest is determined for each patient by precisely defining the margins of each graft&#xD;
             when the reference model (t=0) is merged on the postoperative (t=1) and control model&#xD;
             (t=2). Subsequently, the discrepancy at the ROI surface of both baseline and follow-up&#xD;
             models can be calculated and is evaluated both linearly and volumetrically.&#xD;
  &#xD;
          4. Implant follow-up and analysis of mean marginal bone loss:&#xD;
  &#xD;
             The implant survival rate and complication rate (biological and technical) will be&#xD;
             analysed with the patient history data available in the follow-up period of maximum 12&#xD;
             years after the intervention. Mean marginal bone loss will be measured in orthograde&#xD;
             periapical x-rays mesial and distal of the implants installed in the allogenic grafts.&#xD;
             The periapical x-rays after loading serve as baseline and the radiological bone loss in&#xD;
             the maximum follow-up period available is measured.&#xD;
  &#xD;
          5. Statistical analysis:&#xD;
  &#xD;
        To compare the change in the overlapping CBCT data of the two groups A and B after surgery&#xD;
        and at follow-up examinations, a descriptive analysis is performed using SPSS Statistics&#xD;
        (Version 22, IBM Corp., Armonk, NY) for the sum of the deviations on the x-, y- and z-axes.&#xD;
        Statistical analyses are performed at both patient and material level. For each test,&#xD;
        p-values with a significance level of p&lt;0.05 will be used.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">January 21, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2023</completion_date>
    <primary_completion_date type="Actual">June 1, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Bone graft volume (Vol, in mm³)</measure>
      <time_frame>t=1 directy after intervention, t=2 6 months after intervention compared to t=0 baseline</time_frame>
      <description>Mean bone graft volume within the region of interest, measured in STL models derived from CBCT scans after the grafting procedure (t=1) and at 6 months follow-up (t=2) from baseline (t=0)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mean linear distance (in mm)</measure>
      <time_frame>t=1 directy after intervention, t=2 6 months after intervention compared to t=0 baseline</time_frame>
      <description>The mean linear deviation of the surface (comparison) of two subjects within the region of interest measured at STL models surface at t1 and t2 from baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean marginal bone loss (in mm)</measure>
      <time_frame>Maximum available follow-up period: from the beginning of the retrospective data analysis period, starting with the radiograph after implant loading until the last available follow-up radiograph; up to a maximum of 11 years, individually for each patient</time_frame>
      <description>The radiological bone loss during the follow-up period available measured in periapical x-rays mesial and distal of the implant shoulder; compared to x-rax record after loading;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Implant survival rate</measure>
      <time_frame>Maximum available follow-up period: from the beginning of the retrospective data analysis, starting after implant insertion until the last available follow-up patient record; up to a maximum of 11 years, individually for each patient</time_frame>
      <description>Analysis, if the implant is in-situ at the follow-up examination; its condition is not specified</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Implant complication rate (biological and technical)</measure>
      <time_frame>Maximum available follow-up period: from the beginning of the retrospective data analysis, starting after implant insertion until the last available follow-up patient record; up to a maximum of 11 years, individually for each patient</time_frame>
      <description>t Type and frequency of complications are analysed for each implant and prosthesis</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Alveolar Ridge Augmentation</condition>
    <arm_group>
      <arm_group_label>Prefabricated allogeneic bone blocks</arm_group_label>
      <description>Group A: horizontal and/or vertical augmentation of Puros® allogeneic bone graft material (Zimmer Biomet, Winterthur, Switzerland) in the upper and/or lower jaw; type: conventional prefabricated bone blocks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>CAD/CAM custom milled allogeneic bone blocks</arm_group_label>
      <description>- Group B: horizontal and/or vertical augmentation of allogeneic bone replacement material Puros® (Zimmer Biomet, Winterthur, Switzerland) in the upper and/or lower jaw; type: individually planned, CAD/CAM custom-produced bone blocks</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Extensive alveolar ridge augmentation with allogeneic bone blocks; dental implant insertion in allogeneic bone graft</intervention_name>
      <description>Alveolar ridge augmentation procedure for extensive bone defect rehabilitation in the upper and/or lower jaw allogeneic bone blocks; dental implant insertion in allogeneic bone graft for oral rehabilitation after 6 month of healing</description>
      <arm_group_label>CAD/CAM custom milled allogeneic bone blocks</arm_group_label>
      <arm_group_label>Prefabricated allogeneic bone blocks</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patient treatment records of the study center of the last 12 years will be filtered for the&#xD;
          treatment under investigation and eligibility criteria described and, if criteria are met,&#xD;
          üatients are included in the retrospective analysis.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Treated with the defined allogeneic bone substitute material&#xD;
  &#xD;
            -  Received the defined standardized intervention&#xD;
  &#xD;
            -  Number of missing teeth in the bone defect region ≥ 3&#xD;
  &#xD;
            -  3 CBCT scans recorded and available: baseline before surgery (t=0), after graft&#xD;
               surgery (t=1) and 6 months after surgery (t=2)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Treated with a different bone substitute material than the one defined for&#xD;
               investigation&#xD;
  &#xD;
            -  Received an other intervention than the defined standardized procedure&#xD;
  &#xD;
            -  Number of missing teeth in the bone defect region &lt; 3&#xD;
  &#xD;
            -  One of the following CBCT scans not available: baseline before surgery (t=0), after&#xD;
               graft surgery (t=1) and 6 months after surgery (t=2)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Department of Stomatology, Faculty of Dentistry, University of Santiago de Compostela</name>
        <address>
          <city>Santiago De Compostela</city>
          <state>A Coruña</state>
          <zip>15782</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Santiago de Compostela</investigator_affiliation>
      <investigator_full_name>Juan Blanco Carrión</investigator_full_name>
      <investigator_title>Prof. Dr. Juan Blanco Carrión</investigator_title>
    </responsible_party>
    <keyword>Allograft</keyword>
    <keyword>Dental Implants</keyword>
    <keyword>Bone Substitutes</keyword>
    <keyword>Three-dimensional Imaging</keyword>
    <keyword>Alveolar Ridge Augmentation</keyword>
    <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/NCT06027710
  org study id: USC 68/2022
  nct id: NCT06027710
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To rehabilitate patients after the loss of their own teeth, dental implants are nowadays the
        therapy of choice if the indication is suitable. In order to successfully place implants in
        the patient's jaw, a sufficient supply of bone in vertical and horizontal dimensions is
        necessary. Human bone is generally always in the process of reconstruction and changes over
        time. If there is not enough substance left for rehabilitation with implants due to previous
        degradation of the alveolar bone, bone augmentation can be performed. For this purpose,
        mainly autogenous, xenogenic or allogenic bone material is used.
  
        Bone augmentation using allografts shows satisfactory results in clinical use and has
        advantages such as elimination of morbidity associated with autogenous bone graft harvesting.
        In addition to the use of conventional and prefabricated graft blocks, it is now possible to
        produce individual allogeneic bone blocks using computer-aided design based on the patient's
        radiological data. After this bone has been placed in the patient, it can be restored with
        implants after a healing phase of about 6 months.
  
        In order to make the treatment as predictable as possible, it is crucial to know how a bone
        augmentation changes over time and whether bone remodelling or resorption occurs. How
        allogeneic bone blocks behave with regard to their stability and treatment success has
        already been investigated in some studies, but to date there is no study that deals with the
        difference between prefabricated, conventional and individually manufactured CAD/CAM
        allogeneic bone blocks.
  
        By retrospectively analysing existing clinical data, the aim is to compare how the two
        methods, prefabricated bone blocks and CAD/CAM-fabricated bone blocks, perform during the
        healing phase.
  
        A virtual volume analysis method of 3D digital imaging data (cone beam computed tomography
        scans) will be performed, which allows not only linear punctual evaluation but also area and
        volumetric analysis. Furthermore, the in the grafts inserted dental implants will be examined
        in terms of survival rate, complication rate and marginal bone loss by evaluation of the
        available follow-up records of up to 12 years.
  A clinical retrospective cohort study is planned in a non-invasive, observational study
        design.
  
        The study will be conducted at a single university centre: the Department of Department of
        Stomatology (Periodontology), Faculty of Dentistry, University of Santiago de Compostela,
        Spain.
  
        The study will be conducted in the following steps:
  
          1. Identification of the patient population:
  
             The cohort for the retrospective study will be filtered from the patient data of the
             Department of Stomatology (Periodontology) of the University of Santiago de Compostela.
             Data from all patients who have received one of the following two treatments in the last
             12 years will be selected and examined:
  
               -  Group A: horizontal and/or vertical augmentation of Puros® allogeneic bone graft
                  material (Zimmer Biomet, Winterthur, Switzerland) in the upper and/or lower jaw;
                  type: conventional prefabricated bone blocks.
  
               -  Group B: horizontal and/or vertical augmentation of allogeneic bone graft material
                  Puros® (Zimmer Biomet, Winterthur, Switzerland) in the upper and/or lower jaw;
                  Type: individually planned, CAD/CAM-produced bone blocks
  
          2. Data extraction:
  
             The following clinical data of the patients are collected for retrospective analysis:
  
               -  The patients anamnesis with age at the time of surgery, gender, smoking habits at
                  the time of surgery and during the period of follow-up examinations up to 12 years
                  after surgery
  
               -  The patients treatment history: Statements about the treatment and follow-up
                  examinations during the period up to 12 years after the intervention, statements
                  about adverse events and complications during the intervention or in the period of
                  follow-up examinations up to 12 years after surgery, intraoral clinical photographs
  
             The following radiological data of patients from both groups are used for evaluation:
             cone beam computed tomography data sets for volumetric evaluation and conventional
             x-rays for implant follow-up investigation. In detail the last CBCT scan before surgery
             (preoperative, t=0); the first CBCT scan directly after surgery (postoperative, t=1);
             the CBCT scan at 6 months after surgery (control, t=2); all periapical X-rays in the
             follow-up period of maximum 12 years after the surgery (Follow-up 1, Follow-up 2,
             Follow-up 3...) of the bone blocks and the therein inserted implants.
  
             To ensure that no conclusion be drawn about the identity of the patient, the data are
             pseudonymised by the investigating clinicians. The following type of pseudonymisation of
             the data takes place: the evaluation of the data is pseudonymised, i.e. the patient's
             name is replaced by another characteristic (number and letter, e.g. patient 1a, patient
             2a, etc.). In this way, cases can be distinguished from patients and no conclusions can
             be drawn about patients.
  
          3. Digital data analysis:
  
             Standard tesselation langugage (STL) data are evaluated linearly and also
             volumetrically. First, STL models are created from the patients' DICOM data. The
             pre-operative model serves as the baseline model for each patient. This data is imported
             into CAD analysis software (GOM Inspect, GOM GmbH, Braunschweig, Germany). A region of
             interest is determined for each patient by precisely defining the margins of each graft
             when the reference model (t=0) is merged on the postoperative (t=1) and control model
             (t=2). Subsequently, the discrepancy at the ROI surface of both baseline and follow-up
             models can be calculated and is evaluated both linearly and volumetrically.
  
          4. Implant follow-up and analysis of mean marginal bone loss:
  
             The implant survival rate and complication rate (biological and technical) will be
             analysed with the patient history data available in the follow-up period of maximum 12
             years after the intervention. Mean marginal bone loss will be measured in orthograde
             periapical x-rays mesial and distal of the implants installed in the allogenic grafts.
             The periapical x-rays after loading serve as baseline and the radiological bone loss in
             the maximum follow-up period available is measured.
  
          5. Statistical analysis:
  
        To compare the change in the overlapping CBCT data of the two groups A and B after surgery
        and at follow-up examinations, a descriptive analysis is performed using SPSS Statistics
        (Version 22, IBM Corp., Armonk, NY) for the sum of the deviations on the x-, y- and z-axes.
        Statistical analyses are performed at both patient and material level. For each test,
        p-values with a significance level of p<0.05 will be used.
  observational model: Case-Control
  time perspective: Retrospective
  measure: Bone graft volume (Vol, in mm³)
  time frame: t=1 directy after intervention, t=2 6 months after intervention compared to t=0 baseline
  description: Mean bone graft volume within the region of interest, measured in STL models derived from CBCT scans after the grafting procedure (t=1) and at 6 months follow-up (t=2) from baseline (t=0)
  measure: Mean linear distance (in mm)
  time frame: t=1 directy after intervention, t=2 6 months after intervention compared to t=0 baseline
  description: The mean linear deviation of the surface (comparison) of two subjects within the region of interest measured at STL models surface at t1 and t2 from baseline
  measure: Mean marginal bone loss (in mm)
  time frame: Maximum available follow-up period: from the beginning of the retrospective data analysis period, starting with the radiograph after implant loading until the last available follow-up radiograph; up to a maximum of 11 years, individually for each patient
  description: The radiological bone loss during the follow-up period available measured in periapical x-rays mesial and distal of the implant shoulder; compared to x-rax record after loading;
  measure: Implant survival rate
  time frame: Maximum available follow-up period: from the beginning of the retrospective data analysis, starting after implant insertion until the last available follow-up patient record; up to a maximum of 11 years, individually for each patient
  description: Analysis, if the implant is in-situ at the follow-up examination; its condition is not specified
  measure: Implant complication rate (biological and technical)
  time frame: Maximum available follow-up period: from the beginning of the retrospective data analysis, starting after implant insertion until the last available follow-up patient record; up to a maximum of 11 years, individually for each patient
  description: t Type and frequency of complications are analysed for each implant and prosthesis
  arm group label: Prefabricated allogeneic bone blocks
  description: Group A: horizontal and/or vertical augmentation of Puros® allogeneic bone graft material (Zimmer Biomet, Winterthur, Switzerland) in the upper and/or lower jaw; type: conventional prefabricated bone blocks.
  arm group label: CAD/CAM custom milled allogeneic bone blocks
  description: - Group B: horizontal and/or vertical augmentation of allogeneic bone replacement material Puros® (Zimmer Biomet, Winterthur, Switzerland) in the upper and/or lower jaw; type: individually planned, CAD/CAM custom-produced bone blocks
  intervention type: Procedure
  intervention name: Extensive alveolar ridge augmentation with allogeneic bone blocks; dental implant insertion in allogeneic bone graft
  description: Alveolar ridge augmentation procedure for extensive bone defect rehabilitation in the upper and/or lower jaw allogeneic bone blocks; dental implant insertion in allogeneic bone graft for oral rehabilitation after 6 month of healing
  arm group label: CAD/CAM custom milled allogeneic bone blocks
  arm group label: Prefabricated allogeneic bone blocks
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Spain
  responsible party type: Principal Investigator
  investigator affiliation: University of Santiago de Compostela
  investigator full name: Juan Blanco Carrión
  investigator title: Prof. Dr. Juan Blanco Carrión
  sharing ipd: No