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/NCT05988645</url>
    </required_header>
    <id_info>
      <org_study_id>MW II-CIP</org_study_id>
      <nct_id>NCT05988645</nct_id>
    </id_info>
    <brief_title>Performance and Safety of MiWEndo-assisted Colonoscopy (MiWEndo II)</brief_title>
    <official_title>Performance and Safety of MiWEndo-assisted Colonoscopy: MiWEndo II (Pivotal Study)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>MiWEndo Solutions S.L.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>MiWEndo Solutions S.L.</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 study involves the planned use of a new microwave-based device during colonoscopy&#xD;
        procedures in 50 patients to assess the performance and safety of its use for detection of&#xD;
        colorectal polyps and lack of normal clinical practice modification. The device is a final&#xD;
        design version, which has been previously tested in several preclinical studies (including&#xD;
        phantom studies, an ex vivo study with human tissues, and an in vivo study with porcine&#xD;
        model) and in a pilot study in humans (NCT05477836)&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is designed as a single-center prospective, non-comparative study in 50 patients,&#xD;
        whereby data will be subject to an analytical description, rather than to a statistical&#xD;
        treatment (refer to Statistical design and analysis).&#xD;
  &#xD;
        In this study the principal aims are to assess the performance and safety of the device for&#xD;
        the detection of colorectal polyps when used as an accessory to colonoscopy. Relevant claims&#xD;
        to verify in this study are that the device will detect in first instance polyps not detected&#xD;
        initially with the endoscopic image and can be used without ADEs, without any change in the&#xD;
        current clinical practice, as well as without any major difficulty by the endoscopist,&#xD;
        neither in the preparation nor in the use of the device during exploration.&#xD;
  &#xD;
        In addition, in the first phase of the study (n=15 patients), the study aims to gather real&#xD;
        clinical data with the use of the device to optimise the processing software that will be key&#xD;
        to demonstrate MiWEndo's performance on the second part of the study (n=35 patients).&#xD;
  &#xD;
        Consequently, principal and secondary objectives of this investigation, are:&#xD;
  &#xD;
        Principal objectives:&#xD;
  &#xD;
          -  To assess the performance of MiWEndo-assisted colonoscopy in the detection of colorectal&#xD;
             polyps.&#xD;
  &#xD;
          -  To assess the safety of MiWEndo-assisted colonoscopy.&#xD;
  &#xD;
        Secondary objectives:&#xD;
  &#xD;
          -  To assess the feasibility of performing a complete colonoscopy using the MiWEndo device.&#xD;
  &#xD;
          -  To assess the perception of difficulty by the endoscopist when the device is used.&#xD;
  &#xD;
          -  To assess the operator learning curve with MiWEndo-assisted colonoscopy to guide future&#xD;
             recommendations for training.&#xD;
  &#xD;
          -  To provide exploratory analysis of differences in MiWEndo-assisted colonoscopy in&#xD;
             different groups of patients to guide future RCT.&#xD;
  &#xD;
          -  To assess the patient's comfort.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">September 22, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 22, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Single Group Assignment Traditional safety and performance study, following a single-center prospective and noncomparative.</intervention_model_description>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of polyps</measure>
      <time_frame>During the procedure.</time_frame>
      <description>With MiWEndo assisted colonoscopy, detect at least one polyp before colonoscopy in 10% of patients.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of adverse events.</measure>
      <time_frame>During the procedure and up to 2 weeks after.</time_frame>
      <description>Number of adverse events related with the use of the MiWEndo using the lexicon proposed by the American Society of Gastrointestinal Endoscopy (ASGE) (Cotton PB et al. GIE 2010;71:446-54).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of mural injuries.</measure>
      <time_frame>During the procedure and up to 2 weeks after.</time_frame>
      <description>Mural injuries related with the use of the MiWEndo.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Rate of cecal intubation (yes/no).</measure>
      <time_frame>During procedure.</time_frame>
      <description>As a relevant parameter for assessing the impact of MiWEndo-assisted colonoscopy on the normal clinical practice, this parameter will be measured as complete colonoscopy (yes/no). In case cecum could not be reached, the distance reached will be measured (either in cm or anatomically, indicating what segment of the colon has been reached).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of colon explored (cm).</measure>
      <time_frame>During the procedure.</time_frame>
      <description>In case cecum could not be reached, the distance will be measured (in cm).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time reaching cecum and completing (min). Time for reaching the cecum and completing the colonoscopy (in min) will be measured as a relevant parameter for assessing the impact of MiWEndo-assisted colonoscopy in the clinical practice.</measure>
      <time_frame>During procedure.</time_frame>
      <description>Time for reaching the cecum and completing the colonoscopy (in min) will be measured as a relevant parameter for assessing the impact of MiWEndo-assisted colonoscopy in the clinical practice.&#xD;
  Time for reaching the cecum and completing the colonoscopy (in min) will be measured as a relevant parameter for assessing the impact of MiWEndo-assisted colonoscopy in the clinical practice.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number and size (adenomas and polyps).</measure>
      <time_frame>During procedure.</time_frame>
      <description>The number and size of all lesions (adenomas and all polyps) detected with MiWEndo-assisted colonoscopy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>True positives (TP), False positives (FP), False negatives (FN).</measure>
      <time_frame>During procedure.</time_frame>
      <description>The concordance with the lesions detected by the standard colonoscopy (TP, FP, FN).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patients' comfort.</measure>
      <time_frame>Immediately after the procedure and 2 weeks after.</time_frame>
      <description>Patients' feedback related to colonoscopy using the Gloucester comfort score that ranges from 1 (no discomfort) to 5 (severe discomfort).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perception of difficulty.</measure>
      <time_frame>Immediately after the procedure.</time_frame>
      <description>Perception of difficulty by the endoscopist based on a 5-points Likert scale (very easy to very difficult or very much to very little).</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Colorectal Cancer</condition>
    <condition>Colorectal Polyp</condition>
    <condition>Colorectal Adenoma</condition>
    <condition>Colorectal Adenomatous Polyp</condition>
    <condition>Colorectal Adenocarcinoma</condition>
    <condition>Colorectal Neoplasms</condition>
    <arm_group>
      <arm_group_label>MiWEndo + colonoscope</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All patients will be explored with MiWEndo as an accessory to colonoscopy</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>MiWEndo System</intervention_name>
      <description>All colonoscopies will be performed with high-definition technology. The MiWEndo System will be fitted to the tip of the endoscope before colonoscopy is started and connected to the microwave processor unit. Endoscopies will be performed by experienced endoscopists who will be previously trained on the use of the MiWEndo System. The MiWEndo Analyzer will be managed by the assistant.&#xD;
  At the beginning of the extubation, the MiWEndo System will be turned on and the endoscopist will put music headphones on (blind to the results of MiWEndo).&#xD;
  In case one of them identifies a polyp, the exploration will be stopped and check if it has been detected by the alternative method as well. All the polyps will be resected and sent to the Pathological Department for histological analysis following the usual clinical practice. A stopwatch will be used to measure both total procedure time and withdrawal time.</description>
      <arm_group_label>MiWEndo + colonoscope</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with previously resected polyps.&#xD;
  &#xD;
            -  Patients with hereditary polyposis syndromes.&#xD;
  &#xD;
            -  Patients with Lynch Syndrome.&#xD;
  &#xD;
            -  Patients with familial cancer. These criteria will ensure the probability of finding&#xD;
               polyps during the explorations.&#xD;
  &#xD;
          All the patients will give written informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients at a high risk of having major complications as perforation or hemorrhage or&#xD;
               in whom the possibility of performing a complete colonoscopy is reduced, including:&#xD;
               patients with known colonic strictures, total or partial colectomy, acute&#xD;
               diverticulitis, abdominal surgery, inflammatory bowel disease, suspected or proven&#xD;
               lower gastrointestinal bleeding, non-correctable coagulopathy or&#xD;
               anticoagulant/clopidogrel therapy during procedure, inadequate bowel cleansing or&#xD;
               previous incomplete colonoscopy.&#xD;
  &#xD;
            -  ASA-IV patients.&#xD;
  &#xD;
            -  Urgent colonoscopy.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 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>
    <keyword>microwave imaging</keyword>
    <keyword>colonoscopy</keyword>
    <keyword>early diagnosis</keyword>
    <keyword>colorectal cancer screening</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Colorectal Neoplasms</mesh_term>
      <mesh_term>Adenoma</mesh_term>
      <mesh_term>Adenomatous Polyps</mesh_term>
      <mesh_term>Polyps</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/NCT05988645
  org study id: MW II-CIP
  nct id: NCT05988645
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The study involves the planned use of a new microwave-based device during colonoscopy
        procedures in 50 patients to assess the performance and safety of its use for detection of
        colorectal polyps and lack of normal clinical practice modification. The device is a final
        design version, which has been previously tested in several preclinical studies (including
        phantom studies, an ex vivo study with human tissues, and an in vivo study with porcine
        model) and in a pilot study in humans (NCT05477836)
  This study is designed as a single-center prospective, non-comparative study in 50 patients,
        whereby data will be subject to an analytical description, rather than to a statistical
        treatment (refer to Statistical design and analysis).
  
        In this study the principal aims are to assess the performance and safety of the device for
        the detection of colorectal polyps when used as an accessory to colonoscopy. Relevant claims
        to verify in this study are that the device will detect in first instance polyps not detected
        initially with the endoscopic image and can be used without ADEs, without any change in the
        current clinical practice, as well as without any major difficulty by the endoscopist,
        neither in the preparation nor in the use of the device during exploration.
  
        In addition, in the first phase of the study (n=15 patients), the study aims to gather real
        clinical data with the use of the device to optimise the processing software that will be key
        to demonstrate MiWEndo's performance on the second part of the study (n=35 patients).
  
        Consequently, principal and secondary objectives of this investigation, are:
  
        Principal objectives:
  
          -  To assess the performance of MiWEndo-assisted colonoscopy in the detection of colorectal
             polyps.
  
          -  To assess the safety of MiWEndo-assisted colonoscopy.
  
        Secondary objectives:
  
          -  To assess the feasibility of performing a complete colonoscopy using the MiWEndo device.
  
          -  To assess the perception of difficulty by the endoscopist when the device is used.
  
          -  To assess the operator learning curve with MiWEndo-assisted colonoscopy to guide future
             recommendations for training.
  
          -  To provide exploratory analysis of differences in MiWEndo-assisted colonoscopy in
             different groups of patients to guide future RCT.
  
          -  To assess the patient's comfort.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Single Group Assignment Traditional safety and performance study, following a single-center prospective and noncomparative.
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Number of polyps
  time frame: During the procedure.
  description: With MiWEndo assisted colonoscopy, detect at least one polyp before colonoscopy in 10% of patients.
  measure: Number of adverse events.
  time frame: During the procedure and up to 2 weeks after.
  description: Number of adverse events related with the use of the MiWEndo using the lexicon proposed by the American Society of Gastrointestinal Endoscopy (ASGE) (Cotton PB et al. GIE 2010;71:446-54).
  measure: Number of mural injuries.
  time frame: During the procedure and up to 2 weeks after.
  description: Mural injuries related with the use of the MiWEndo.
  measure: Rate of cecal intubation (yes/no).
  time frame: During procedure.
  description: As a relevant parameter for assessing the impact of MiWEndo-assisted colonoscopy on the normal clinical practice, this parameter will be measured as complete colonoscopy (yes/no). In case cecum could not be reached, the distance reached will be measured (either in cm or anatomically, indicating what segment of the colon has been reached).
  measure: Length of colon explored (cm).
  time frame: During the procedure.
  description: In case cecum could not be reached, the distance will be measured (in cm).
  measure: Time reaching cecum and completing (min). Time for reaching the cecum and completing the colonoscopy (in min) will be measured as a relevant parameter for assessing the impact of MiWEndo-assisted colonoscopy in the clinical practice.
  time frame: During procedure.
  description: Time for reaching the cecum and completing the colonoscopy (in min) will be measured as a relevant parameter for assessing the impact of MiWEndo-assisted colonoscopy in the clinical practice.
  Time for reaching the cecum and completing the colonoscopy (in min) will be measured as a relevant parameter for assessing the impact of MiWEndo-assisted colonoscopy in the clinical practice.
  measure: Number and size (adenomas and polyps).
  time frame: During procedure.
  description: The number and size of all lesions (adenomas and all polyps) detected with MiWEndo-assisted colonoscopy.
  measure: True positives (TP), False positives (FP), False negatives (FN).
  time frame: During procedure.
  description: The concordance with the lesions detected by the standard colonoscopy (TP, FP, FN).
  measure: Patients' comfort.
  time frame: Immediately after the procedure and 2 weeks after.
  description: Patients' feedback related to colonoscopy using the Gloucester comfort score that ranges from 1 (no discomfort) to 5 (severe discomfort).
  measure: Perception of difficulty.
  time frame: Immediately after the procedure.
  description: Perception of difficulty by the endoscopist based on a 5-points Likert scale (very easy to very difficult or very much to very little).
  arm group label: MiWEndo + colonoscope
  arm group type: Experimental
  description: All patients will be explored with MiWEndo as an accessory to colonoscopy
  intervention type: Device
  intervention name: MiWEndo System
  description: All colonoscopies will be performed with high-definition technology. The MiWEndo System will be fitted to the tip of the endoscope before colonoscopy is started and connected to the microwave processor unit. Endoscopies will be performed by experienced endoscopists who will be previously trained on the use of the MiWEndo System. The MiWEndo Analyzer will be managed by the assistant.
  At the beginning of the extubation, the MiWEndo System will be turned on and the endoscopist will put music headphones on (blind to the results of MiWEndo).
  In case one of them identifies a polyp, the exploration will be stopped and check if it has been detected by the alternative method as well. All the polyps will be resected and sent to the Pathological Department for histological analysis following the usual clinical practice. A stopwatch will be used to measure both total procedure time and withdrawal time.
  arm group label: MiWEndo + colonoscope
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Colorectal Neoplasms
  mesh term: Adenoma
  mesh term: Adenomatous Polyps
  mesh term: Polyps