<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/NCT03037034</url>
  </required_header>
  <id_info>
    <org_study_id>Novel Forcep Srip Method</org_study_id>
    <nct_id>NCT03037034</nct_id>
  </id_info>
  <brief_title>Novel Endoscopic Resection of Upper Gastrointestinal Subepithelial Tumors Originating From the Muscularis Propria</brief_title>
  <official_title>Novel Endoscopic Resection of Upper Gastrointestinal Subepithelial Tumors Originating From the Muscularis Propria: a Promising Forcep Strip Method</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Korea University Anam Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Korea University Anam Hospital</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>
      Endoscopic submucosal tumor resection using biopsy forceps was performed for 11 consecutive&#xD;
      patients who had clinical indications for lesion removal. Following the injection around a&#xD;
      submucosal tumor, the adjacent mucosa or submucosa was grasped with the forceps and pulled&#xD;
      away to form a &quot;tent&quot;. The tissue was dissected using an electrocoagulating current. In&#xD;
      brief, the tumor was dissected from the muscularis propria layer and then carefully removed&#xD;
      using forceps. Demographic data, indication for intervention, safety of the procedure and&#xD;
      follow-up will be assessed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After the target lesion was identified, several marking dots were made around the lesion,&#xD;
      using the hot biopsy forcep. A 0.9% saline solution mixed with epinephrine (1:10,000) and&#xD;
      indigo carmine dye was injected along the border of the tumor to raise the gastric mucosa.&#xD;
      Then, a circumferential incision was made along the margin of the targeted lesion, using the&#xD;
      hot biopsy forceps, and the superficial mucosa was removed. Repeated injection was performed&#xD;
      into the submucosal layer. The surrounding tissue was then carefully dissected using the hot&#xD;
      biopsy forceps to the level of the deepest submucosal layer. The adjacent tissue was grasped&#xD;
      using the forceps and pulled away, forming a &quot;tent&quot;. To ensure complete resection, the&#xD;
      muscular fibers and stalks that connected the tumor to the propria layer were shelled along&#xD;
      the capsule of the tumor, using the coagulating forceps. The investigators used a coagulating&#xD;
      forceps when strip the tissue of the outer longitudinal layer. Visible blood vessels in the&#xD;
      submucosal layer were directly coagulated using coagulating forceps. After the lesion was&#xD;
      removed, further visible blood vessels were coagulated. The hot biopsy forcep was used to&#xD;
      apply a forced coagulation current (80 W, Effect 2, VIO300D; Erbe, Germany). However,&#xD;
      coagulating forceps with a soft coagulation current (60 W, Effect 6, VIO300D; Erbe, Germany)&#xD;
      were used to cut muscle fibers adjacent to the tumor or hemostasis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2015</start_date>
  <completion_date type="Actual">November 30, 2016</completion_date>
  <primary_completion_date type="Actual">November 30, 2016</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>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Complete resection rate</measure>
    <time_frame>1 week</time_frame>
    <description>Proportion of study patients with a histologically confirmed diagnosis after Forcep Strip Method</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The mean procedure time</measure>
    <time_frame>1day</time_frame>
    <description>procedure time of submucosal tumor removal using forcep strip method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mean tumor size</measure>
    <time_frame>1day</time_frame>
    <description>tumor size of submucosal tumor removed by forcep strip method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the mean hospitalization time</measure>
    <time_frame>1week</time_frame>
    <description>patient hospitalization time during submucosal tumor removal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>5 days</time_frame>
    <description>Peri-interventional adverse events whether related or not</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumor status after endoscopic resection</measure>
    <time_frame>10 months</time_frame>
    <description>Local result during follow up after Forcep Strip Method</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Gastric Subepithelial Tumor</condition>
  <arm_group>
    <arm_group_label>Forcep Strip Method Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients who have Gastrointestinal Subepithelial Tumors Originating from the Muscularis Propria are enrolled</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Forcep</intervention_name>
    <description>Following the injection around a submucosal tumor, the adjacent mucosa or submucosa was grasped with the forceps and pulled away to form a &quot;tent&quot;. The tissue was dissected using an electrocoagulating current.</description>
    <arm_group_label>Forcep Strip Method Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. the tumor size had increased on the follow up gastroscopy,&#xD;
&#xD;
          2. the EUS showed a well demarcated GI SET, or&#xD;
&#xD;
          3. they requested an endoscopic excision because the tumor was causing them anxiety.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. they had predominantly extraluminal growth,&#xD;
&#xD;
          2. they were ill demarcated, or&#xD;
&#xD;
          3. the EUS showed adjacent lymph nodes with a malignant appearance.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hoon Jai Chun</last_name>
    <role>Principal Investigator</role>
    <affiliation>Korea University Anam Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Korea University Anam Hospital</name>
      <address>
        <city>Seoul</city>
        <state>Anamdong , Seongbuk-gu</state>
        <zip>136-705</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>January 30, 2017</last_update_submitted>
  <last_update_submitted_qc>January 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Korea University Anam Hospital</investigator_affiliation>
    <investigator_full_name>In-Kyung Yoo</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </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/NCT03037034
org study id: Novel Forcep Srip Method
nct id: NCT03037034
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Endoscopic submucosal tumor resection using biopsy forceps was performed for 11 consecutive
      patients who had clinical indications for lesion removal. Following the injection around a
      submucosal tumor, the adjacent mucosa or submucosa was grasped with the forceps and pulled
      away to form a "tent". The tissue was dissected using an electrocoagulating current. In
      brief, the tumor was dissected from the muscularis propria layer and then carefully removed
      using forceps. Demographic data, indication for intervention, safety of the procedure and
      follow-up will be assessed.
After the target lesion was identified, several marking dots were made around the lesion,
      using the hot biopsy forcep. A 0.9% saline solution mixed with epinephrine (1:10,000) and
      indigo carmine dye was injected along the border of the tumor to raise the gastric mucosa.
      Then, a circumferential incision was made along the margin of the targeted lesion, using the
      hot biopsy forceps, and the superficial mucosa was removed. Repeated injection was performed
      into the submucosal layer. The surrounding tissue was then carefully dissected using the hot
      biopsy forceps to the level of the deepest submucosal layer. The adjacent tissue was grasped
      using the forceps and pulled away, forming a "tent". To ensure complete resection, the
      muscular fibers and stalks that connected the tumor to the propria layer were shelled along
      the capsule of the tumor, using the coagulating forceps. The investigators used a coagulating
      forceps when strip the tissue of the outer longitudinal layer. Visible blood vessels in the
      submucosal layer were directly coagulated using coagulating forceps. After the lesion was
      removed, further visible blood vessels were coagulated. The hot biopsy forcep was used to
      apply a forced coagulation current (80 W, Effect 2, VIO300D; Erbe, Germany). However,
      coagulating forceps with a soft coagulation current (60 W, Effect 6, VIO300D; Erbe, Germany)
      were used to cut muscle fibers adjacent to the tumor or hemostasis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Complete resection rate
time frame: 1 week
description: Proportion of study patients with a histologically confirmed diagnosis after Forcep Strip Method
measure: The mean procedure time
time frame: 1day
description: procedure time of submucosal tumor removal using forcep strip method
measure: mean tumor size
time frame: 1day
description: tumor size of submucosal tumor removed by forcep strip method
measure: the mean hospitalization time
time frame: 1week
description: patient hospitalization time during submucosal tumor removal
measure: Adverse Events
time frame: 5 days
description: Peri-interventional adverse events whether related or not
measure: Tumor status after endoscopic resection
time frame: 10 months
description: Local result during follow up after Forcep Strip Method
arm group label: Forcep Strip Method Treatment
arm group type: Experimental
description: patients who have Gastrointestinal Subepithelial Tumors Originating from the Muscularis Propria are enrolled
intervention type: Device
intervention name: Forcep
description: Following the injection around a submucosal tumor, the adjacent mucosa or submucosa was grasped with the forceps and pulled away to form a "tent". The tissue was dissected using an electrocoagulating current.
arm group label: Forcep Strip Method Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Hoon Jai Chun
role: Principal Investigator
affiliation: Korea University Anam Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Korea University Anam Hospital
investigator full name: In-Kyung Yoo
investigator title: Clinical Professor
sharing ipd: No