<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/NCT04422236</url>
  </required_header>
  <id_info>
    <org_study_id>DM-Delta-01</org_study_id>
    <nct_id>NCT04422236</nct_id>
  </id_info>
  <brief_title>A Post-market, Observational Registry With the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Bariatric Surgery</brief_title>
  <acronym>STAP-Delta</acronym>
  <official_title>A Post-market, Observational Registry With the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Bariatric Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duomed</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duomed</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 purpose of this observational registry is to evaluate the safety and performance of the&#xD;
      easyEndoTM Universal Linear Cutting Stapler and reloads from Ezisurg Medical when used to&#xD;
      create anastomoses during laparoscopic bariatric surgery. The goal of the study will be&#xD;
      achieved by assessing the device performance and by reporting of peri- and postoperative&#xD;
      complications in a prospectively maintained database.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 28, 2020</start_date>
  <completion_date type="Anticipated">May 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2025</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>24 Months</target_duration>
  <primary_outcome>
    <measure>To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.</measure>
    <time_frame>At index procedure</time_frame>
    <description>Conversion rate, number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.</measure>
    <time_frame>At discharge, up to 1 week</time_frame>
    <description>Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.</measure>
    <time_frame>Follow-up 1: 3 weeks after the procedure</time_frame>
    <description>Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.</measure>
    <time_frame>Follow-up 2: 8 weeks after the procedure</time_frame>
    <description>Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.</measure>
    <time_frame>Follow-up 3: 6 months after the procedure</time_frame>
    <description>Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.</measure>
    <time_frame>Follow-up 4: 12 months after the procedure</time_frame>
    <description>Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.</measure>
    <time_frame>Follow-up 5: 18 months after the procedure</time_frame>
    <description>Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.</measure>
    <time_frame>Follow-up 6: 24 months after the procedure</time_frame>
    <description>Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Device performance</measure>
    <time_frame>At index procedure</time_frame>
    <description>Number of procedures with technical success defined as bariatric surgery as intended, without technical difficulties and without conversion to open laparotomy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device performance</measure>
    <time_frame>At index procedure</time_frame>
    <description>Assessment of device performance (e.g. sharpness of the blade, staple-line formation, etc.).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical efficacy</measure>
    <time_frame>Follow-up 1: 3 weeks after the procedure</time_frame>
    <description>Weight loss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical efficacy</measure>
    <time_frame>Follow-up 2: 8 weeks after the procedure</time_frame>
    <description>Weight loss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical efficacy</measure>
    <time_frame>Follow-up 3: 6 months after the procedure</time_frame>
    <description>Weight loss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical efficacy</measure>
    <time_frame>Follow-up 4: 12 months after the procedure</time_frame>
    <description>Weight loss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical efficacy</measure>
    <time_frame>Follow-up 5: 18 months after the procedure</time_frame>
    <description>Weight loss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical efficacy</measure>
    <time_frame>Follow-up 6: 24 months after the procedure</time_frame>
    <description>Weight loss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical efficacy</measure>
    <time_frame>Follow-up 4: 12 months after the procedure</time_frame>
    <description>Comorbidity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical efficacy</measure>
    <time_frame>Follow-up 6: 24 months after the procedure</time_frame>
    <description>Comorbidity</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Obesity</condition>
  <condition>Roux-en-Y Gastric Bypass</condition>
  <condition>Gastrectomy</condition>
  <condition>Mini Gastric Bypass</condition>
  <arm_group>
    <arm_group_label>Obese patients eligible for laparoscopic bariatric surgery</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)</intervention_name>
    <description>Investigational device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical). Device for creation of anastomoses during laparoscopic bariatric surgery, manufactured by Ezisurg Medical.</description>
    <arm_group_label>Obese patients eligible for laparoscopic bariatric surgery</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Obese patients eligible for laparoscopic bariatric surgery. This registry will collect data&#xD;
        from 200 laparoscopic bariatric procedures in which anastomoses are created with the&#xD;
        easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient ≥ 18 years of age at registry entry.&#xD;
&#xD;
          -  Patient and investigator signed and dated the informed consent form prior to the&#xD;
             index-procedure.&#xD;
&#xD;
          -  Patient has a BMI ≥ 35 kg/m2, with one or more related co-morbidities.&#xD;
&#xD;
          -  Patient has a BMI ≥ 40 kg/m2.&#xD;
&#xD;
          -  Patient is eligible for laparoscopic bariatric surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient is unable / unwilling to provide informed consent.&#xD;
&#xD;
          -  Patient has a history of bariatric surgery.&#xD;
&#xD;
          -  Patient is unable to comply with the registry protocol or proposed follow-up visits.&#xD;
&#xD;
          -  Patient has a contra-indication for laparoscopic bariatric surgery.&#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>Bart Smet, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>AZ Delta vzw</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>AZ Delta vzw</name>
      <address>
        <city>Roeselare</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 1, 2023</last_update_submitted>
  <last_update_submitted_qc>June 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04422236
org study id: DM-Delta-01
nct id: NCT04422236
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this observational registry is to evaluate the safety and performance of the
      easyEndoTM Universal Linear Cutting Stapler and reloads from Ezisurg Medical when used to
      create anastomoses during laparoscopic bariatric surgery. The goal of the study will be
      achieved by assessing the device performance and by reporting of peri- and postoperative
      complications in a prospectively maintained database.
observational model: Case-Only
time perspective: Prospective
measure: To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.
time frame: At index procedure
description: Conversion rate, number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
measure: To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.
time frame: At discharge, up to 1 week
description: Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
measure: To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.
time frame: Follow-up 1: 3 weeks after the procedure
description: Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
measure: To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.
time frame: Follow-up 2: 8 weeks after the procedure
description: Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
measure: To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.
time frame: Follow-up 3: 6 months after the procedure
description: Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
measure: To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.
time frame: Follow-up 4: 12 months after the procedure
description: Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
measure: To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.
time frame: Follow-up 5: 18 months after the procedure
description: Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
measure: To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.
time frame: Follow-up 6: 24 months after the procedure
description: Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
measure: Device performance
time frame: At index procedure
description: Number of procedures with technical success defined as bariatric surgery as intended, without technical difficulties and without conversion to open laparotomy.
measure: Device performance
time frame: At index procedure
description: Assessment of device performance (e.g. sharpness of the blade, staple-line formation, etc.).
measure: Clinical efficacy
time frame: Follow-up 1: 3 weeks after the procedure
description: Weight loss
measure: Clinical efficacy
time frame: Follow-up 2: 8 weeks after the procedure
description: Weight loss
measure: Clinical efficacy
time frame: Follow-up 3: 6 months after the procedure
description: Weight loss
measure: Clinical efficacy
time frame: Follow-up 4: 12 months after the procedure
description: Weight loss
measure: Clinical efficacy
time frame: Follow-up 5: 18 months after the procedure
description: Weight loss
measure: Clinical efficacy
time frame: Follow-up 6: 24 months after the procedure
description: Weight loss
measure: Clinical efficacy
time frame: Follow-up 4: 12 months after the procedure
description: Comorbidity
measure: Clinical efficacy
time frame: Follow-up 6: 24 months after the procedure
description: Comorbidity
arm group label: Obese patients eligible for laparoscopic bariatric surgery
intervention type: Device
intervention name: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
description: Investigational device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical). Device for creation of anastomoses during laparoscopic bariatric surgery, manufactured by Ezisurg Medical.
arm group label: Obese patients eligible for laparoscopic bariatric surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bart Smet, Dr.
role: Principal Investigator
affiliation: AZ Delta vzw
facility: 
country: Belgium
responsible party type: Sponsor
sharing ipd: No