<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/NCT02183207</url>
  </required_header>
  <id_info>
    <org_study_id>PEG by EG Scan</org_study_id>
    <nct_id>NCT02183207</nct_id>
  </id_info>
  <brief_title>PEG by Introducer Method Via EG Scan</brief_title>
  <official_title>Percutaneous Endoscopic Gastrostomy by Introducer Method Via Visualization Through E.G. ScanTM</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Catholic University of Korea</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>IntroMedic Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>The Catholic University of Korea</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Percutaneous endoscopic gastrostomy(PEG) by introducer method has been proven to be safe and&#xD;
      easy to perform. However, it is limited by its need to be performed in an endoscopy unit.&#xD;
      E.G. ScanTM is an new portable ultrathin endoscope, capable of being performed in any&#xD;
      hospital setting and introduced via nasal approach. Our aim is to prove that PEG by&#xD;
      introducer method via E.G. ScanTM is feasible and safe. This will allow PEG to be done at&#xD;
      hospitals and medical facilities without endoscopic units.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2013</start_date>
  <completion_date type="Anticipated">August 2015</completion_date>
  <primary_completion_date type="Anticipated">July 2015</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>The success rate of PEG via introducer method by visualization through EG ScanTM</measure>
    <time_frame>up to 1 year from PEG insertion</time_frame>
    <description>up to 1 year from PEG insertion or until patient death if within one year</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complication rate</measure>
    <time_frame>up to one year from PEG insertion</time_frame>
    <description>Complication rate including bleeding, infection, gastric perforation and leakage of intragastric contents</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Dysphagia</condition>
  <condition>Aspiration</condition>
  <condition>Esophageal Stenosis</condition>
  <arm_group>
    <arm_group_label>PEG insertion arm via EG Scan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Percutaneous endoscopic insertion of gastrostomy via visualization through E.G. ScanTM</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Percutaneous Endoscopic Gastrostomy</intervention_name>
    <description>Percutaneous Endoscopic Gastrostomy by introducer method via visualization through E.G. ScanTM</description>
    <arm_group_label>PEG insertion arm via EG Scan</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Require percutaneous endoscopic gastrostomy placement due to inability to achieve oral&#xD;
             feeding for at least one month&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with esophageal ulcers or strictures&#xD;
&#xD;
          -  Patients with prior esophageal/gastric surgery (excepting gastric wedge resection)&#xD;
&#xD;
          -  Patients at high risk of gastric bleeding, mechanical ileus or gastrointestinal&#xD;
             perforation&#xD;
&#xD;
          -  Other patients in whom the study investigators consider unfit for inclusion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul St Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>137-701</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Myong Ki Baeg, MD</last_name>
      <phone>82-2-2258-2045</phone>
      <email>biosoul@hanmail.net</email>
    </contact>
    <contact_backup>
      <last_name>Chul-Hyun Lim, MD, PhD</last_name>
      <phone>82-2-2258-2046</phone>
      <email>djluck@hanmail.net</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <results_reference>
    <citation>Dormann AJ, Wejda B, Kahl S, Huchzermeyer H, Ebert MP, Malfertheiner P. Long-term results with a new introducer method with gastropexy for percutaneous endoscopic gastrostomy. Am J Gastroenterol. 2006 Jun;101(6):1229-34. doi: 10.1111/j.1572-0241.2006.00541.x.</citation>
    <PMID>16771943</PMID>
  </results_reference>
  <results_reference>
    <citation>Yuki M, Amano Y, Komazawa Y, Fukuhara H, Shizuku T, Yamamoto S, Kinoshita Y. Unsedated transnasal small-caliber esophagogastroduodenoscopy in elderly and bedridden patients. World J Gastroenterol. 2009 Nov 28;15(44):5586-91. doi: 10.3748/wjg.15.5586.</citation>
    <PMID>19938199</PMID>
  </results_reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>August 11, 2013</study_first_submitted>
  <study_first_submitted_qc>July 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 8, 2014</study_first_posted>
  <last_update_submitted>July 2, 2014</last_update_submitted>
  <last_update_submitted_qc>July 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Catholic University of Korea</investigator_affiliation>
    <investigator_full_name>Myung-gui Choi</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>percutaneous endoscopic gastrostomy</keyword>
  <keyword>Introducer method</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esophageal Stenosis</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/NCT02183207
org study id: PEG by EG Scan
nct id: NCT02183207
lead sponsor: 
collaborator: 
has dmc: No
Percutaneous endoscopic gastrostomy(PEG) by introducer method has been proven to be safe and
      easy to perform. However, it is limited by its need to be performed in an endoscopy unit.
      E.G. ScanTM is an new portable ultrathin endoscope, capable of being performed in any
      hospital setting and introduced via nasal approach. Our aim is to prove that PEG by
      introducer method via E.G. ScanTM is feasible and safe. This will allow PEG to be done at
      hospitals and medical facilities without endoscopic units.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The success rate of PEG via introducer method by visualization through EG ScanTM
time frame: up to 1 year from PEG insertion
description: up to 1 year from PEG insertion or until patient death if within one year
measure: Complication rate
time frame: up to one year from PEG insertion
description: Complication rate including bleeding, infection, gastric perforation and leakage of intragastric contents
arm group label: PEG insertion arm via EG Scan
arm group type: Experimental
description: Percutaneous endoscopic insertion of gastrostomy via visualization through E.G. ScanTM
intervention type: Procedure
intervention name: Percutaneous Endoscopic Gastrostomy
description: Percutaneous Endoscopic Gastrostomy by introducer method via visualization through E.G. ScanTM
arm group label: PEG insertion arm via EG Scan
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
country: Korea, Republic of
citation: Dormann AJ, Wejda B, Kahl S, Huchzermeyer H, Ebert MP, Malfertheiner P. Long-term results with a new introducer method with gastropexy for percutaneous endoscopic gastrostomy. Am J Gastroenterol. 2006 Jun;101(6):1229-34. doi: 10.1111/j.1572-0241.2006.00541.x.
PMID: 16771943
citation: Yuki M, Amano Y, Komazawa Y, Fukuhara H, Shizuku T, Yamamoto S, Kinoshita Y. Unsedated transnasal small-caliber esophagogastroduodenoscopy in elderly and bedridden patients. World J Gastroenterol. 2009 Nov 28;15(44):5586-91. doi: 10.3748/wjg.15.5586.
PMID: 19938199
responsible party type: Principal Investigator
investigator affiliation: The Catholic University of Korea
investigator full name: Myung-gui Choi
investigator title: Professor
mesh term: Esophageal Stenosis