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/NCT06030518</url>
    </required_header>
    <id_info>
      <org_study_id>SCH-2497</org_study_id>
      <nct_id>NCT06030518</nct_id>
    </id_info>
    <brief_title>Robot-controlled Magnet-Assisted Capsule Endoscopy</brief_title>
    <acronym>MACE</acronym>
    <official_title>Feasibility and Acceptability of Robot-controlled Magnet-Assisted Capsule Endoscopy Compared to Conventional Endoscopy of the Upper Gastrointestinal Tract in Children</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sheffield Children's NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sheffield Children's NHS Foundation Trust</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>
        Examination of the upper gastrointestinal tract (oesophagus, stomach and duodenum) involves&#xD;
        passing a flexible tubular endoscope through the mouth into the stomach. It is commonly&#xD;
        performed to identify the cause of abdominal pain, indigestion, diarrhoea and anaemia. As it&#xD;
        is an invasive and uncomfortable test, it is usually performed under general anaesthetic in&#xD;
        children. However, children and their parents worry about the nature of the procedure which&#xD;
        does incur a small risk of both the anaesthetic and the endoscopy.&#xD;
  &#xD;
        A capsule endoscope is a large pill-sized device containing a battery powered camera which&#xD;
        can be swallowed. It was first devised to examine the small bowel (which begins with the&#xD;
        duodenum and ends in the colon or large bowel) which is difficult to reach with conventional&#xD;
        endoscopes and has been used in children aged over eight years since at least 2005. It is&#xD;
        extremely well tolerated. However, it does not provide a comprehensive view of the whole&#xD;
        surface area of the stomach which has a convoluted shape, large volume and is collapsed in&#xD;
        the fasted state.&#xD;
  &#xD;
        Recent research in adults shows that a capsule can be steered around a water-filled stomach&#xD;
        using two joysticks to control the polarity and distance of an external robot magnet from the&#xD;
        patient. This is much better tolerated and appears to be almost as good a diagnostic tool as&#xD;
        conventional endoscopy. It has yet to be studied in children. We intend to compare patient&#xD;
        acceptability of capsule endoscopy and gastroscopy and see if it is cost effective.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A capsule endoscope is a swallowable pill camera (26x11mm) which images the GI tract as it&#xD;
        passes through under the action of peristalsis. It is a non-invasive test which does not&#xD;
        require sedation or general anaesthesia. It was originally designed to image the small bowel,&#xD;
        which is inaccessible to conventional endoscopy, and was subsequently adapted for use in the&#xD;
        colon by the addition of a second camera (one at each end of the device) and a higher frame&#xD;
        acquisition rate. The unusual configuration of the oesophagus, stomach and duodenum, the&#xD;
        capacious and non-uniform shape of the stomach and the fact that it is collapsed in the&#xD;
        fasted state presented barriers to extending examination to the upper gastrointestinal tract.&#xD;
        However, recent studies in adult patients with anaemia, suspected upper gastrointestinal&#xD;
        bleeding and dyspepsia suggest that capsules which are steered around the stomach in&#xD;
        swallowed water using external magnets achieve comparable diagnostic yields to OGD. Control&#xD;
        is achieved using a magnet suspended above the patient who is recumbent on an examination&#xD;
        couch. The examiner manipulates two joysticks to alter the polarity of the magnet and its&#xD;
        distance from the patient to steer the capsule around whilst conducting a live inspection of&#xD;
        the stomach on a computer monitor. An additional benefit is that the small bowel can be&#xD;
        examined following passage of the capsule through the stomach, which further improves the&#xD;
        diagnostic yield.&#xD;
  &#xD;
        Studies in the adult population suggest that capsule endoscopy of small bowel, colon and&#xD;
        upper gastrointestinal tract is much better tolerated than conventional (invasive) endoscopy.&#xD;
        Capsule endoscopy is a recommended investigation for suspected small bowel disease in&#xD;
        children over the age of two years. Young children may need a small bowel capsule to be&#xD;
        delivered endoscopically, but 85- 90% of children of over eight years of age are able to&#xD;
        swallow it with water and 82% of 28 children expressed a preference for capsule endoscopy&#xD;
        over conventional endoscopy (done under deep sedation or general anaesthesia) in one study.&#xD;
        Magnetically controlled upper GI capsule endoscopy may offer a better tolerated, more&#xD;
        acceptable alternative to OGD in children. Secondly, the ability to provide upper GI imaging&#xD;
        without general anaesthetic may be a more cost-effective approach. Finally, such a&#xD;
        non-invasive diagnostic tool could be used as a near-patient test, performed in the patients'&#xD;
        community rather than an acute hospital setting.&#xD;
  &#xD;
        This study proposes comparing patient acceptability and cost-effectiveness of capsule&#xD;
        endoscopy compared to OGD in children.&#xD;
  &#xD;
        The joystick-controlled robot magnet used for upper GI capsule endoscopy is on the Clinical&#xD;
        Investigation Unit at the Royal Hallamshire Hospital, Sheffield, where it is being used in&#xD;
        clinical trials and routine clinical practice in adults. It was the first of four systems&#xD;
        (two in France and one in Hungary) to be installed outside of China.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 9, 2022</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 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>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Acceptability of upper GI capsule endoscopy</measure>
      <time_frame>One year</time_frame>
      <description>Compare acceptability of upper GI capsule endoscopy and OGD in children using UPC questionnaire.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Diagnostic Yield</measure>
      <time_frame>One year</time_frame>
      <description>Compare diagnostic yield of upper GI capsule endoscopy and OGD in children</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Prevalence of small bowel pathology</measure>
      <time_frame>One year</time_frame>
      <description>Determine the prevalence of small bowel pathology as a cause for abdominal pain in children.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Abdominal Pain</condition>
    <condition>Upper Gastrointestinal Symptoms</condition>
    <arm_group>
      <arm_group_label>Patient undergoing upper Gi endoscopy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Children attending Sheffield Childrens' Hospital Gastroenterology out-patients departments between the ages of 11-16 years of age who require OGD to investigate abdominal pain or discomfort will be invited to take part in the study.&#xD;
  Interventions&#xD;
  The study will begin when capsule endoscopy is performed by a Clinical Research Fellow at the Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Trust.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Magnet Assisted Capsule Endoscopy</intervention_name>
      <description>Procedures will be performed in the morning after an overnight fast. Patients wear a belt containing sensors and a data recorder. The patient will be asked to drink 500-1000ml (containing 80mg simethicone; volume depending on tolerance) immediately before swallowing the capsule. Gastric examination will proceed as previously described for a robot-controlled magnetic assisted capsule endoscopy. The whole procedure is anticipated to take 30-60 minutes. The patient will be discharged from hospital on completion of gastric examination but if clinically indicated will wear the belt for small bowel capsule study for eight hours to allow small bowel examination before detaching the equipment and returning it the following day. On completion of examination, the patient will be asked to complete a questionnaire about their capsule endoscopy experience. The full study (upper GI tract and small bowel) will then be downloaded onto the computer for formal reading and reporting.</description>
      <arm_group_label>Patient undergoing upper Gi endoscopy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Abdominal pain requiring investigation by OGD&#xD;
  &#xD;
            -  Participant must be willing to undergo both procedures (i.e. ingestion of the capsule&#xD;
               and standard of care Oesophago-gastro duodenoscopy (OGD)&#xD;
  &#xD;
            -  Age 11-16 years inclusive&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Dysphagia&#xD;
  &#xD;
            -  Inability to swallow capsule&#xD;
  &#xD;
            -  Small bowel stricture&#xD;
  &#xD;
            -  Disease associated with small bowel stricturing (Crohn's disease, previous small bowel&#xD;
               surgery, previous abdominal or pelvic radiation therapy, long term daily (&gt;6 months)&#xD;
               non-steroidal anti-inflammatory drug consumption)&#xD;
  &#xD;
            -  Pacemaker or other implantable electrical cardiac or neurological device&#xD;
  &#xD;
            -  Unable to speak English&#xD;
  &#xD;
            -  Participants who are pregnant or who have implantable electronic devices cannot take&#xD;
               part in the study. Depending on their age and pubertal status the female patients will&#xD;
               be offered a pregnancy test prior to any examinations. Capsule endoscopy is not&#xD;
               advised during pregnancy.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>11 Years</minimum_age>
      <maximum_age>16 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Shishu Sharma</last_name>
      <role>Study Chair</role>
      <affiliation>Sheffield Childrens NHS FT</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Shishu Sharma</last_name>
      <phone>01143053827</phone>
      <email>shishusharma@nhs.net</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mark Mcalindon</last_name>
      <email>mark.Mcalindon@nhs.net</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Sheffield Childrens NHS FT</name>
        <address>
          <city>Sheffield</city>
          <state>South Yorkshire</state>
          <zip>S10 2TH</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>September 21, 2022</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 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 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Upper GI endoscopy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Abdominal Pain</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/NCT06030518
  org study id: SCH-2497
  nct id: NCT06030518
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Examination of the upper gastrointestinal tract (oesophagus, stomach and duodenum) involves
        passing a flexible tubular endoscope through the mouth into the stomach. It is commonly
        performed to identify the cause of abdominal pain, indigestion, diarrhoea and anaemia. As it
        is an invasive and uncomfortable test, it is usually performed under general anaesthetic in
        children. However, children and their parents worry about the nature of the procedure which
        does incur a small risk of both the anaesthetic and the endoscopy.
  
        A capsule endoscope is a large pill-sized device containing a battery powered camera which
        can be swallowed. It was first devised to examine the small bowel (which begins with the
        duodenum and ends in the colon or large bowel) which is difficult to reach with conventional
        endoscopes and has been used in children aged over eight years since at least 2005. It is
        extremely well tolerated. However, it does not provide a comprehensive view of the whole
        surface area of the stomach which has a convoluted shape, large volume and is collapsed in
        the fasted state.
  
        Recent research in adults shows that a capsule can be steered around a water-filled stomach
        using two joysticks to control the polarity and distance of an external robot magnet from the
        patient. This is much better tolerated and appears to be almost as good a diagnostic tool as
        conventional endoscopy. It has yet to be studied in children. We intend to compare patient
        acceptability of capsule endoscopy and gastroscopy and see if it is cost effective.
  A capsule endoscope is a swallowable pill camera (26x11mm) which images the GI tract as it
        passes through under the action of peristalsis. It is a non-invasive test which does not
        require sedation or general anaesthesia. It was originally designed to image the small bowel,
        which is inaccessible to conventional endoscopy, and was subsequently adapted for use in the
        colon by the addition of a second camera (one at each end of the device) and a higher frame
        acquisition rate. The unusual configuration of the oesophagus, stomach and duodenum, the
        capacious and non-uniform shape of the stomach and the fact that it is collapsed in the
        fasted state presented barriers to extending examination to the upper gastrointestinal tract.
        However, recent studies in adult patients with anaemia, suspected upper gastrointestinal
        bleeding and dyspepsia suggest that capsules which are steered around the stomach in
        swallowed water using external magnets achieve comparable diagnostic yields to OGD. Control
        is achieved using a magnet suspended above the patient who is recumbent on an examination
        couch. The examiner manipulates two joysticks to alter the polarity of the magnet and its
        distance from the patient to steer the capsule around whilst conducting a live inspection of
        the stomach on a computer monitor. An additional benefit is that the small bowel can be
        examined following passage of the capsule through the stomach, which further improves the
        diagnostic yield.
  
        Studies in the adult population suggest that capsule endoscopy of small bowel, colon and
        upper gastrointestinal tract is much better tolerated than conventional (invasive) endoscopy.
        Capsule endoscopy is a recommended investigation for suspected small bowel disease in
        children over the age of two years. Young children may need a small bowel capsule to be
        delivered endoscopically, but 85- 90% of children of over eight years of age are able to
        swallow it with water and 82% of 28 children expressed a preference for capsule endoscopy
        over conventional endoscopy (done under deep sedation or general anaesthesia) in one study.
        Magnetically controlled upper GI capsule endoscopy may offer a better tolerated, more
        acceptable alternative to OGD in children. Secondly, the ability to provide upper GI imaging
        without general anaesthetic may be a more cost-effective approach. Finally, such a
        non-invasive diagnostic tool could be used as a near-patient test, performed in the patients'
        community rather than an acute hospital setting.
  
        This study proposes comparing patient acceptability and cost-effectiveness of capsule
        endoscopy compared to OGD in children.
  
        The joystick-controlled robot magnet used for upper GI capsule endoscopy is on the Clinical
        Investigation Unit at the Royal Hallamshire Hospital, Sheffield, where it is being used in
        clinical trials and routine clinical practice in adults. It was the first of four systems
        (two in France and one in Hungary) to be installed outside of China.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Acceptability of upper GI capsule endoscopy
  time frame: One year
  description: Compare acceptability of upper GI capsule endoscopy and OGD in children using UPC questionnaire.
  measure: Diagnostic Yield
  time frame: One year
  description: Compare diagnostic yield of upper GI capsule endoscopy and OGD in children
  measure: Prevalence of small bowel pathology
  time frame: One year
  description: Determine the prevalence of small bowel pathology as a cause for abdominal pain in children.
  arm group label: Patient undergoing upper Gi endoscopy
  arm group type: Experimental
  description: Children attending Sheffield Childrens' Hospital Gastroenterology out-patients departments between the ages of 11-16 years of age who require OGD to investigate abdominal pain or discomfort will be invited to take part in the study.
  Interventions
  The study will begin when capsule endoscopy is performed by a Clinical Research Fellow at the Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Trust.
  intervention type: Diagnostic Test
  intervention name: Magnet Assisted Capsule Endoscopy
  description: Procedures will be performed in the morning after an overnight fast. Patients wear a belt containing sensors and a data recorder. The patient will be asked to drink 500-1000ml (containing 80mg simethicone; volume depending on tolerance) immediately before swallowing the capsule. Gastric examination will proceed as previously described for a robot-controlled magnetic assisted capsule endoscopy. The whole procedure is anticipated to take 30-60 minutes. The patient will be discharged from hospital on completion of gastric examination but if clinically indicated will wear the belt for small bowel capsule study for eight hours to allow small bowel examination before detaching the equipment and returning it the following day. On completion of examination, the patient will be asked to complete a questionnaire about their capsule endoscopy experience. The full study (upper GI tract and small bowel) will then be downloaded onto the computer for formal reading and reporting.
  arm group label: Patient undergoing upper Gi endoscopy
  criteria: 
  gender: All
  minimum age: 11 Years
  maximum age: 16 Years
  healthy volunteers: No
  last name: Shishu Sharma
  role: Study Chair
  affiliation: Sheffield Childrens NHS FT
  last name: Shishu Sharma
  phone: 01143053827
  email: shishusharma@nhs.net
  last name: Mark Mcalindon
  email: mark.Mcalindon@nhs.net
  facility: 
  status: Recruiting
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Abdominal Pain
  sharing ipd: No