<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/NCT03306966</url>
  </required_header>
  <id_info>
    <org_study_id>ST-02</org_study_id>
    <nct_id>NCT03306966</nct_id>
  </id_info>
  <brief_title>Assessing the Safety and Performance of the Endoscopic Linear Cutter Stapler and Reloads (Frankenman) in Colectomy</brief_title>
  <official_title>Assessing the Safety and Performance of the Single Use Endoscopic Linear Cutter Stapler and Reloads (Frankenman) in Colectomy: a Monocentric Post-market Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duomed</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duomed</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>
      The purpose of this observational study is to evaluate the safety and performance of the&#xD;
      Single Use Endoscopic Linear Cutter Stapler and Reloads from Frankenman used in&#xD;
      (hemi)colectomy to remove tumors and create anastomoses in patients with cancer in the&#xD;
      ascending colon. The goal of the study will be achieved by assessing the device performance&#xD;
      and reporting of peri- and postoperative complications in a prospectively maintained&#xD;
      database.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Design modification&#xD;
  </why_stopped>
  <start_date type="Anticipated">May 1, 2018</start_date>
  <completion_date type="Anticipated">January 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>Number of patients with adverse events related to the index-procedure.</measure>
    <time_frame>3 to 4 weeks follow-up</time_frame>
    <description>Determination of peri- and postoperative anastomotic leaks and intra-intestinal/intra-abdominal bleeding.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with adverse events related to the index-procedure.</measure>
    <time_frame>3 months follow-up</time_frame>
    <description>Determination of peri- and postoperative anastomotic leaks and intra-intestinal/intra-abdominal bleeding.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with adverse events related to the index-procedure.</measure>
    <time_frame>6 months follow-up</time_frame>
    <description>Determination of peri- and postoperative anastomotic leaks and intra-intestinal/intra-abdominal bleeding.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of adverse device effects.</measure>
    <time_frame>3 to 4 weeks follow-up</time_frame>
    <description>Determination of the sharpness of the blade and occurrence of disruption of the staple line.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of adverse device effects.</measure>
    <time_frame>3 months follow-up</time_frame>
    <description>Determination of the sharpness of the blade and occurrence of disruption of the staple line.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of adverse device effects.</measure>
    <time_frame>6 months follow-up</time_frame>
    <description>Determination of the sharpness of the blade and occurrence of disruption of the staple line.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with peri- and early/late postoperative complications related to the open and laparoscopic colectomy.</measure>
    <time_frame>3 to 4 weeks follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with peri- and early/late postoperative complications related to the open and laparoscopic colectomy.</measure>
    <time_frame>3 months follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with peri- and early/late postoperative complications related to the open and laparoscopic colectomy.</measure>
    <time_frame>6 months follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with colectomy related re-interventions.</measure>
    <time_frame>3 to 4 weeks follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with colectomy related re-interventions.</measure>
    <time_frame>3 months follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with colectomy related re-interventions.</measure>
    <time_frame>6 months follow-up</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Colon Cancer</condition>
  <arm_group>
    <arm_group_label>Colon cancer patients</arm_group_label>
    <description>Patients with colon cancer (ascending colon) eligible for laparoscopic or open segmental colectomy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Endoscopic Linear Cutter Stapler and Reloads (Frankenman)</intervention_name>
    <description>The Single Use Endoscopic Linear Cutter Stapler and Reloads from Frankenman received CE-mark in April 2013. It is used to staple and simultaneously divide tissue from the central line.</description>
    <arm_group_label>Colon cancer patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with colon cancer (ascending colon) eligible for laparoscopic or open segmental&#xD;
        colectomy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age at study entry is at least 18 years.&#xD;
&#xD;
          -  Patient must sign and date the informed consent form prior to the index-procedure.&#xD;
&#xD;
          -  Patient has a tumor in the ascending colon.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient is pregnant.&#xD;
&#xD;
          -  Patient has inflammatory bowel disease (ulcerative colitis, Crohn's disease).&#xD;
&#xD;
          -  Patient has symptomatic diverticulitis.&#xD;
&#xD;
          -  Patient has bowel trauma.&#xD;
&#xD;
          -  Patient has peritoneal carcinomatosis.&#xD;
&#xD;
          -  Patient is known to be, or suspected of being unable to comply with the study protocol&#xD;
             or proposed follow-up visits.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kurt Van Der Speeten, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>ZOL, Genk</affiliation>
  </overall_official>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>October 6, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>May 30, 2018</last_update_submitted>
  <last_update_submitted_qc>May 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ascending colon</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT03306966
org study id: ST-02
nct id: NCT03306966
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this observational study is to evaluate the safety and performance of the
      Single Use Endoscopic Linear Cutter Stapler and Reloads from Frankenman used in
      (hemi)colectomy to remove tumors and create anastomoses in patients with cancer in the
      ascending colon. The goal of the study will be achieved by assessing the device performance
      and reporting of peri- and postoperative complications in a prospectively maintained
      database.
observational model: Case-Only
time perspective: Prospective
measure: Number of patients with adverse events related to the index-procedure.
time frame: 3 to 4 weeks follow-up
description: Determination of peri- and postoperative anastomotic leaks and intra-intestinal/intra-abdominal bleeding.
measure: Number of patients with adverse events related to the index-procedure.
time frame: 3 months follow-up
description: Determination of peri- and postoperative anastomotic leaks and intra-intestinal/intra-abdominal bleeding.
measure: Number of patients with adverse events related to the index-procedure.
time frame: 6 months follow-up
description: Determination of peri- and postoperative anastomotic leaks and intra-intestinal/intra-abdominal bleeding.
measure: Number of adverse device effects.
time frame: 3 to 4 weeks follow-up
description: Determination of the sharpness of the blade and occurrence of disruption of the staple line.
measure: Number of adverse device effects.
time frame: 3 months follow-up
description: Determination of the sharpness of the blade and occurrence of disruption of the staple line.
measure: Number of adverse device effects.
time frame: 6 months follow-up
description: Determination of the sharpness of the blade and occurrence of disruption of the staple line.
measure: Number of patients with peri- and early/late postoperative complications related to the open and laparoscopic colectomy.
time frame: 3 to 4 weeks follow-up
measure: Number of patients with peri- and early/late postoperative complications related to the open and laparoscopic colectomy.
time frame: 3 months follow-up
measure: Number of patients with peri- and early/late postoperative complications related to the open and laparoscopic colectomy.
time frame: 6 months follow-up
measure: Number of patients with colectomy related re-interventions.
time frame: 3 to 4 weeks follow-up
measure: Number of patients with colectomy related re-interventions.
time frame: 3 months follow-up
measure: Number of patients with colectomy related re-interventions.
time frame: 6 months follow-up
arm group label: Colon cancer patients
description: Patients with colon cancer (ascending colon) eligible for laparoscopic or open segmental colectomy.
intervention type: Device
intervention name: Endoscopic Linear Cutter Stapler and Reloads (Frankenman)
description: The Single Use Endoscopic Linear Cutter Stapler and Reloads from Frankenman received CE-mark in April 2013. It is used to staple and simultaneously divide tissue from the central line.
arm group label: Colon cancer patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kurt Van Der Speeten, Dr
role: Principal Investigator
affiliation: ZOL, Genk
responsible party type: Sponsor
mesh term: Colonic Neoplasms