<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/NCT03000361</url>
  </required_header>
  <id_info>
    <org_study_id>MSCT</org_study_id>
    <nct_id>NCT03000361</nct_id>
  </id_info>
  <brief_title>Motorized Spiral Colonoscopy Trial: A First Feasibility Trial</brief_title>
  <acronym>MSCT</acronym>
  <official_title>Motorized Spiral Colonoscopy Trial (MSCT): A First Feasibility Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Evangelisches Krankenhaus Düsseldorf</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Olympus</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Evangelisches Krankenhaus Düsseldorf</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to assess the feasibility and the safety of the Novel Motorized&#xD;
      Spiral Endoscope to examine the colon. The study is conceived as proof of concept trial with&#xD;
      the primary aim to achieve a cecal intubation rate of at least 90 % according to quality&#xD;
      guidelines recommendations. All other clinically relevant quality parameters of standard&#xD;
      colonoscopy will be evaluated as secondary aims comparable to our recent trial. This study&#xD;
      represents the first clinical evaluation of using a motorized spiral assisted endoscope for&#xD;
      examination of the colon with potential advantages for patients in terms of effectiveness and&#xD;
      convenience of colonoscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Colonoscopy has been widely accepted for the diagnosis and treatment of colon diseases.&#xD;
      Properly performed, colonoscopy is generally safe, accurate, and well-tolerated. Diagnostic&#xD;
      colonoscopy is the preferred method to evaluate the colon in most patients with large-bowel&#xD;
      symptoms, iron deficiency anemia, abnormal results on radiographic studies of the colon,&#xD;
      positive results on colorectal cancer (CRC) screening tests, post-polypectomy and post-cancer&#xD;
      resection surveillance, and diagnosis and surveillance in inflammatory bowel disease. In&#xD;
      addition, colonoscopy has been introduced for CRC screening in some Western countries e.g. in&#xD;
      the United States and Germany. Recent trials showed that screening colonoscopy has a large&#xD;
      potential for prevention and early detection of colorectal cancer. Diagnostic colonoscopy is&#xD;
      usually combined with endoscopic resection of small and medium sized polyps and flat&#xD;
      neoplastic lesions. Patients in whom larger lesions are detected at a diagnostic colonoscopy&#xD;
      are usually rescheduled for therapeutic colonoscopy in an appropriate setting.&#xD;
&#xD;
      Quality parameters for colonoscopy were recently reported. In terms of intraprocedural&#xD;
      indicators a cecal intubation rate of ≥ 90% for all cases of colonoscopy is widely accepted.&#xD;
      Even experienced endoscopists classify up to 10% of colonoscopies as difficult and intubation&#xD;
      of the cecum may then be impossible. A recent study evaluated the efficacy and safety of&#xD;
      repeating colonoscopy in 520 patients with prior incomplete colonoscopy. Reasons for failure&#xD;
      to complete colonoscopy in referring institutions were &quot;looping/redundant colon&quot; in 53.8% of&#xD;
      the cases, &quot;sigmoid fixation/angulation&quot; in 38.8%, &quot;both sigmoid angulation and looping&#xD;
      colon&quot; in 5.8% of the cases. Issues with sedation caused failures in 1.5% of the patients.&#xD;
      Conventional colonoscopy can be difficult in particular in these anatomical variations&#xD;
      because pushing the endoscope tends to form loops with limited or no advancement of the tip&#xD;
      of the instrument. Techniques like alternating pushing and pulling the endoscope or external&#xD;
      compression of the abdomen are used to overcome these limitations. Loop formation and&#xD;
      stretching the colon with the adjacent mesenterium as well as external compression are&#xD;
      inconvenient or even painful for the patient. In addition these maneuvers prolong the&#xD;
      procedural duration. We recently compared the use of ultrathin colonoscopies with standard&#xD;
      colonoscope in a randomized trial in terms of cecal intubation rate, level of sedation,&#xD;
      amount of propofol needed for sedation, number of external compressions, pain score patient&#xD;
      satisfaction and other parameters. The results indicate that these parameters can be well&#xD;
      used for evaluation of a new technique of colonoscopy.&#xD;
&#xD;
      Spiral assisted endoscopy is based on a completely different concept of advancing an&#xD;
      endoscope by pleating of bowel on the instrumentation shaft by rotation. This technique has&#xD;
      been widely used for antegrade enteroscopy. For this purpose a manually rotatable overtube is&#xD;
      used through which a thin flexible enteroscope is inserted. The distal end of the overtube&#xD;
      contains a raised spiral thread for pleating the small intestine over the overtube. By&#xD;
      manually rotating the spiral element the bowel pleats onto the overtube, allowing the&#xD;
      operator to access and visualize the more distal portions of the small intestine. Spiral&#xD;
      assisted endoscopy has been also approved and evaluated for retrograde enteroscopy via the&#xD;
      anal route. It promises advantage for intubation of the cecum and the terminal ileum by its&#xD;
      principle of pleating at least parts of the colon with consecutive shortening and less loop&#xD;
      formation. These effects should reduce the need for external compression and they may cause&#xD;
      less pain for patients. In addition, the spiral should stabilize the position of the&#xD;
      colonoscope which is advantageous for careful examination and targeted interventions. Spiral&#xD;
      overtube-assisted colonoscopy achieved a success rate of cecal intubation in 92% of 24&#xD;
      patients in whom conventional colonoscopy had failed. However conventional spiral endoscopy&#xD;
      is cumbersome to use and requires assistance by a second endoscopist for its appropriate use.&#xD;
&#xD;
      The Novel Motorized Spiral Endoscope represents a new technology which offers all of the&#xD;
      advantageous options of spiral-assisted endoscopy with a faster and less invasive approach.&#xD;
      The system is similar to other currently marketed endoscopes in that it incorporates a&#xD;
      flexible insertion tube, light source, digital imaging, and channels for passing accessories&#xD;
      for sample collection or therapeutic interventions. The system is unique in that it&#xD;
      incorporates a user-controlled motor contained in the endoscope's handle to rotate a spiral&#xD;
      cuff located on the endoscope's insertion tube. Rotation of this cuff, which has soft&#xD;
      spiral-shaped &quot;fins&quot;, pleats the colon on to the endoscope's insertion tube, thereby allowing&#xD;
      rapid and atraumatic access into the colon. The system also includes a display monitor, a&#xD;
      motor control unit, device to display measured motor current and signal torque, and a set of&#xD;
      foot pedals. It is currently being evaluated in a prospective study in patients with&#xD;
      indications for antegrade enteroscopy (&quot;European Novel Motorized Spiral Endoscopy Trial&#xD;
      (ENMSET)) in the two centers conducting this study. So far more than 60 patients were&#xD;
      successfully examined without major adverse events.&#xD;
&#xD;
      The aim of this study is to assess the feasibility and the safety of the Novel Motorized&#xD;
      Spiral Endoscope to examine the colon. The study is conceived as proof of concept trial with&#xD;
      the primary aim to achieve a cecal intubation rate of at least 90 % according to quality&#xD;
      guidelines recommendations. All other clinically relevant quality parameters of standard&#xD;
      colonoscopy will be evaluated as secondary aims comparable to our recent trial. This study&#xD;
      represents the first clinical evaluation of using a motorized spiral assisted endoscope for&#xD;
      examination of the colon with potential advantages for patients in terms of effectiveness and&#xD;
      convenience of colonoscopy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">February 1, 2017</completion_date>
  <primary_completion_date type="Actual">February 1, 2017</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cecal intubation rate</measure>
    <time_frame>3 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ileum intubation rate</measure>
    <time_frame>3 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure time</measure>
    <time_frame>3 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rate of need for external compression</measure>
    <time_frame>3 days</time_frame>
    <description>external compression necessary during intervention, yes/no?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adenoma detection rate</measure>
    <time_frame>3 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>success rate for removal of polyps</measure>
    <time_frame>3 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>amount of propofol needed for sedation</measure>
    <time_frame>3 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>maximum level of sedation during procedure</measure>
    <time_frame>3 days</time_frame>
    <description>sedation depth assessed by ESGE-guideline, level 1-3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patient satisfaction score</measure>
    <time_frame>3 days</time_frame>
    <description>1-10 visual analog scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse event rate</measure>
    <time_frame>3 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>maximum pain during procedure</measure>
    <time_frame>3 days</time_frame>
    <description>1-10 visual analog scale</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Colonoscopy</condition>
  <condition>Safety Issues</condition>
  <condition>Adenoma</condition>
  <arm_group>
    <arm_group_label>Motorized Spiral Colonoscopy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Motorized Spiral Colonoscopy (MSC) with the novel motorized spiral endoscope represents a new technology which offers all of the advantageous options of spiral-assisted endoscopy with a faster and less invasive approach</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Motorized Spiral Colonoscopy</intervention_name>
    <description>For any pathological finding during colonoscopy standard endoscopic techniques, e.g. forceps biopsy, injection, endoscopic mucosal resection, argon plasma coagulation</description>
    <arm_group_label>Motorized Spiral Colonoscopy</arm_group_label>
    <other_name>standard endoscopic interventions (not experimental)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Screening for colorectal neoplasia&#xD;
&#xD;
          -  Surveillance after previous polypectomy/endoscopic mucosal resection (EMR)&#xD;
&#xD;
          -  Positive results on colorectal cancer (CRC) screening tests&#xD;
&#xD;
          -  Evaluation of clinical symptoms of non overt gastrointestinal bleeding&#xD;
&#xD;
          -  Indeterminate iron-deficiency anaemia&#xD;
&#xD;
          -  Chronic diarrhoea&#xD;
&#xD;
          -  Indeterminate large-bowel symptoms requiring evaluation for colorectal disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age under 18 years&#xD;
&#xD;
          -  Health status American Society of Anesthesiologists classification (ASA) level ≥ 3&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Known coagulopathy (INR≥2.0, Platelets &lt; 70/nl)&#xD;
&#xD;
          -  Anti-platelet agents or anticoagulants (other than aspirin) within last 7 days&#xD;
&#xD;
          -  History of chronic inflammatory bowel disease&#xD;
&#xD;
          -  Previously identified colorectal polyps/lesions with indication for endoscopic&#xD;
             resection&#xD;
&#xD;
          -  Any medical contraindication to standard colonoscopy&#xD;
&#xD;
          -  Any prior abdominal surgery of the mid or lower gastrointestinal tract (except&#xD;
             uncomplicated appendectomy)&#xD;
&#xD;
          -  Known or suspected bowel obstruction or stenosis&#xD;
&#xD;
          -  Known hemorrhoids 3rd degree&#xD;
&#xD;
          -  Suspected perforation of the GI tract&#xD;
&#xD;
          -  Inability to tolerate sedation for any reason&#xD;
&#xD;
          -  Absence of a signed informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Horst Neuhaus, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Evangelisches Krankenhaus Duesseldorf, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Evangelisches Krankenhaus</name>
      <address>
        <city>Dusseldorf</city>
        <zip>40217</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>July 28, 2017</last_update_submitted>
  <last_update_submitted_qc>July 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Colonoscopy</keyword>
  <keyword>motorized spiral endoscopy</keyword>
  <keyword>adenoma detection rate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03000361
org study id: MSCT
nct id: NCT03000361
lead sponsor: 
collaborator: 
has dmc: No
The aim of this study is to assess the feasibility and the safety of the Novel Motorized
      Spiral Endoscope to examine the colon. The study is conceived as proof of concept trial with
      the primary aim to achieve a cecal intubation rate of at least 90 % according to quality
      guidelines recommendations. All other clinically relevant quality parameters of standard
      colonoscopy will be evaluated as secondary aims comparable to our recent trial. This study
      represents the first clinical evaluation of using a motorized spiral assisted endoscope for
      examination of the colon with potential advantages for patients in terms of effectiveness and
      convenience of colonoscopy.
Colonoscopy has been widely accepted for the diagnosis and treatment of colon diseases.
      Properly performed, colonoscopy is generally safe, accurate, and well-tolerated. Diagnostic
      colonoscopy is the preferred method to evaluate the colon in most patients with large-bowel
      symptoms, iron deficiency anemia, abnormal results on radiographic studies of the colon,
      positive results on colorectal cancer (CRC) screening tests, post-polypectomy and post-cancer
      resection surveillance, and diagnosis and surveillance in inflammatory bowel disease. In
      addition, colonoscopy has been introduced for CRC screening in some Western countries e.g. in
      the United States and Germany. Recent trials showed that screening colonoscopy has a large
      potential for prevention and early detection of colorectal cancer. Diagnostic colonoscopy is
      usually combined with endoscopic resection of small and medium sized polyps and flat
      neoplastic lesions. Patients in whom larger lesions are detected at a diagnostic colonoscopy
      are usually rescheduled for therapeutic colonoscopy in an appropriate setting.

      Quality parameters for colonoscopy were recently reported. In terms of intraprocedural
      indicators a cecal intubation rate of ≥ 90% for all cases of colonoscopy is widely accepted.
      Even experienced endoscopists classify up to 10% of colonoscopies as difficult and intubation
      of the cecum may then be impossible. A recent study evaluated the efficacy and safety of
      repeating colonoscopy in 520 patients with prior incomplete colonoscopy. Reasons for failure
      to complete colonoscopy in referring institutions were "looping/redundant colon" in 53.8% of
      the cases, "sigmoid fixation/angulation" in 38.8%, "both sigmoid angulation and looping
      colon" in 5.8% of the cases. Issues with sedation caused failures in 1.5% of the patients.
      Conventional colonoscopy can be difficult in particular in these anatomical variations
      because pushing the endoscope tends to form loops with limited or no advancement of the tip
      of the instrument. Techniques like alternating pushing and pulling the endoscope or external
      compression of the abdomen are used to overcome these limitations. Loop formation and
      stretching the colon with the adjacent mesenterium as well as external compression are
      inconvenient or even painful for the patient. In addition these maneuvers prolong the
      procedural duration. We recently compared the use of ultrathin colonoscopies with standard
      colonoscope in a randomized trial in terms of cecal intubation rate, level of sedation,
      amount of propofol needed for sedation, number of external compressions, pain score patient
      satisfaction and other parameters. The results indicate that these parameters can be well
      used for evaluation of a new technique of colonoscopy.

      Spiral assisted endoscopy is based on a completely different concept of advancing an
      endoscope by pleating of bowel on the instrumentation shaft by rotation. This technique has
      been widely used for antegrade enteroscopy. For this purpose a manually rotatable overtube is
      used through which a thin flexible enteroscope is inserted. The distal end of the overtube
      contains a raised spiral thread for pleating the small intestine over the overtube. By
      manually rotating the spiral element the bowel pleats onto the overtube, allowing the
      operator to access and visualize the more distal portions of the small intestine. Spiral
      assisted endoscopy has been also approved and evaluated for retrograde enteroscopy via the
      anal route. It promises advantage for intubation of the cecum and the terminal ileum by its
      principle of pleating at least parts of the colon with consecutive shortening and less loop
      formation. These effects should reduce the need for external compression and they may cause
      less pain for patients. In addition, the spiral should stabilize the position of the
      colonoscope which is advantageous for careful examination and targeted interventions. Spiral
      overtube-assisted colonoscopy achieved a success rate of cecal intubation in 92% of 24
      patients in whom conventional colonoscopy had failed. However conventional spiral endoscopy
      is cumbersome to use and requires assistance by a second endoscopist for its appropriate use.

      The Novel Motorized Spiral Endoscope represents a new technology which offers all of the
      advantageous options of spiral-assisted endoscopy with a faster and less invasive approach.
      The system is similar to other currently marketed endoscopes in that it incorporates a
      flexible insertion tube, light source, digital imaging, and channels for passing accessories
      for sample collection or therapeutic interventions. The system is unique in that it
      incorporates a user-controlled motor contained in the endoscope's handle to rotate a spiral
      cuff located on the endoscope's insertion tube. Rotation of this cuff, which has soft
      spiral-shaped "fins", pleats the colon on to the endoscope's insertion tube, thereby allowing
      rapid and atraumatic access into the colon. The system also includes a display monitor, a
      motor control unit, device to display measured motor current and signal torque, and a set of
      foot pedals. It is currently being evaluated in a prospective study in patients with
      indications for antegrade enteroscopy ("European Novel Motorized Spiral Endoscopy Trial
      (ENMSET)) in the two centers conducting this study. So far more than 60 patients were
      successfully examined without major adverse events.

      The aim of this study is to assess the feasibility and the safety of the Novel Motorized
      Spiral Endoscope to examine the colon. The study is conceived as proof of concept trial with
      the primary aim to achieve a cecal intubation rate of at least 90 % according to quality
      guidelines recommendations. All other clinically relevant quality parameters of standard
      colonoscopy will be evaluated as secondary aims comparable to our recent trial. This study
      represents the first clinical evaluation of using a motorized spiral assisted endoscope for
      examination of the colon with potential advantages for patients in terms of effectiveness and
      convenience of colonoscopy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cecal intubation rate
time frame: 3 days
measure: Ileum intubation rate
time frame: 3 days
measure: Procedure time
time frame: 3 days
measure: rate of need for external compression
time frame: 3 days
description: external compression necessary during intervention, yes/no?
measure: adenoma detection rate
time frame: 3 days
measure: success rate for removal of polyps
time frame: 3 days
measure: amount of propofol needed for sedation
time frame: 3 days
measure: maximum level of sedation during procedure
time frame: 3 days
description: sedation depth assessed by ESGE-guideline, level 1-3
measure: patient satisfaction score
time frame: 3 days
description: 1-10 visual analog scale
measure: adverse event rate
time frame: 3 days
measure: maximum pain during procedure
time frame: 3 days
description: 1-10 visual analog scale
arm group label: Motorized Spiral Colonoscopy
arm group type: Experimental
description: Motorized Spiral Colonoscopy (MSC) with the novel motorized spiral endoscope represents a new technology which offers all of the advantageous options of spiral-assisted endoscopy with a faster and less invasive approach
intervention type: Procedure
intervention name: Motorized Spiral Colonoscopy
description: For any pathological finding during colonoscopy standard endoscopic techniques, e.g. forceps biopsy, injection, endoscopic mucosal resection, argon plasma coagulation
arm group label: Motorized Spiral Colonoscopy
other name: standard endoscopic interventions (not experimental)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Horst Neuhaus, MD, PhD
role: Principal Investigator
affiliation: Evangelisches Krankenhaus Duesseldorf, Germany
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Adenoma
sharing ipd: No